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FDA 510(k)

LAPAROTOMY PADS

K-Number: K811769 · 1981-08-07

ApplicantSouth Mountain Medical
Decision Date1981-08-07
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPAROTOMY PADS is the device name listed in this FDA 510(k) record. The listed applicant is South Mountain Medical. It received FDA 510(k) clearance on 1981-08-07 under 510(k) number K811769. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROTOMY PADS?

LAPAROTOMY PADS is a medical device that received FDA 510(k) clearance on 1981-08-07. The listed applicant is South Mountain Medical. The 510(k) number is K811769.

When did LAPAROTOMY PADS receive FDA 510(k) clearance?

LAPAROTOMY PADS received FDA 510(k) clearance on 1981-08-07, under 510(k) number K811769.

Who is the listed applicant for LAPAROTOMY PADS?

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

What is the FDA product code for LAPAROTOMY PADS?

The FDA product code for LAPAROTOMY PADS is GDY.

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Other records listing South Mountain Medical 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.

K853742GAUZE SPONGEK852945HUCK TOWELK851276ACTION PACK831806SUTURE KITS STERILIZED W/GAMA RADIATIONK823485SURE SNIPK812992SURGICAL MASK

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Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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