FDA Device Establishments · JSON-LD · Markdown

PENTAX of America, Inc.

FEI 1000080301 · Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number1000080301
Owner / OperatorHOYA Corporation PENTAX Division (#8030235)
Address3 Paragon Drive, MONTVALE, NJ, US
Registration expiry2026
Initial importer flagY
Registered products1
Product codes (top 20)BZD
Regulation § (21 CFR)868.5905
Proprietary namesFILTER OVERFLOW PROTEC/BACT/W CONNEC 670 (67061); DISPOSABLE TUBING PATIENT TO PUMP MEDELA (67069); SILICONE TUBING JAR TO PUMP MEDELA (67068); VARIO 18 (AC) SUCTION PUMP (67059); DISPOSABLE 1500CC BAG FOR PUMP 67059 (67077); DISPOSABLE 2500CC BAG FOR PUMP 67059 (67078)

External sources

Source: openFDA. Public-domain (CC0).