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FDA 510(k)

SURGITEK FOERSTER MAMMARY BANDAGE

K-Number: K800249 · 1980-02-19

ApplicantMedical Engineering Corp.
Decision Date1980-02-19
Product CodeFRL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGITEK FOERSTER MAMMARY BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1980-02-19 under 510(k) number K800249. The device is classified under product code FRL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK FOERSTER MAMMARY BANDAGE?

SURGITEK FOERSTER MAMMARY BANDAGE is a medical device that received FDA 510(k) clearance on 1980-02-19. The listed applicant is Medical Engineering Corp.. The 510(k) number is K800249.

When did SURGITEK FOERSTER MAMMARY BANDAGE receive FDA 510(k) clearance?

SURGITEK FOERSTER MAMMARY BANDAGE received FDA 510(k) clearance on 1980-02-19, under 510(k) number K800249.

Who is the listed applicant for SURGITEK FOERSTER MAMMARY BANDAGE?

The FDA 510(k) record lists Medical Engineering Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGITEK FOERSTER MAMMARY BANDAGE?

The FDA product code for SURGITEK FOERSTER MAMMARY BANDAGE is FRL.

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Other records listing Medical Engineering Corp. as applicant

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K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

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Related Devices (Code: FRL)

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.

K121898STAY FRESH SKIN FOLD MANAGEMENT TEXTILEQuick-Med Technologies, Inc.K110715INTERDRY SILVERMilliken Healthcare Products, LLCK061615INTERDRY TEXTILE WITH SILVERMilliken ChemicalK931626CARAPACE STERILE COTTON BALLSCarapace, Inc.K914081ICAN COTTON RAYON BALLSIcn Pharmaceuticals, Inc.K811990TRACH CLEANING TRAYAssociated Medical Products Co.

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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