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FDA 510(k)

COVERAGE HBV

K-Number: K964749 · 1996-12-13

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1996-12-13
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COVERAGE HBV is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K964749. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVERAGE HBV?

COVERAGE HBV is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K964749.

When did COVERAGE HBV receive FDA 510(k) clearance?

COVERAGE HBV received FDA 510(k) clearance on 1996-12-13, under 510(k) number K964749.

Who is the listed applicant for COVERAGE HBV?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COVERAGE HBV?

The FDA product code for COVERAGE HBV is LRJ. This falls under the Clinical Lab category.

Related Clinical Trials

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: LRJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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