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FDA 510(k)

AMNIPERF(TM)

K-Number: K926425 · 1994-03-07

ApplicantRaymart Development Co.
Decision Date1994-03-07
Product CodeHGE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMNIPERF(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Raymart Development Co.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K926425. The device is classified under product code HGE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNIPERF(TM)?

AMNIPERF(TM) is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Raymart Development Co.. The 510(k) number is K926425.

When did AMNIPERF(TM) receive FDA 510(k) clearance?

AMNIPERF(TM) received FDA 510(k) clearance on 1994-03-07, under 510(k) number K926425.

Who is the listed applicant for AMNIPERF(TM)?

The FDA 510(k) record lists Raymart Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMNIPERF(TM)?

The FDA product code for AMNIPERF(TM) is HGE.

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Related Devices (Code: HGE)

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.

K951148OBSTI-HOOKOnliK910518GLOVE-N-GEL AMNIOTOMY KITEpcom Medical Systems, Inc.K871087S.C.M.T. PERFORATORSalt Creek Medical TechnologiesK850758AMNIGLOVE & AMNICOTGo Medical Industries Pty. , Ltd.K834177H.R. JAKOBI SURG. INSTRUMENTS #4 30/31Imm Enterprises , Ltd.

Official Source

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

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