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FDA 510(k)

POUCHES, PEEL OPEN, BREATHABLE

K-Number: K771032 · 1977-07-14

ApplicantSurgicot, Inc.
Decision Date1977-07-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POUCHES, PEEL OPEN, BREATHABLE is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K771032. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POUCHES, PEEL OPEN, BREATHABLE?

POUCHES, PEEL OPEN, BREATHABLE is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Surgicot, Inc.. The 510(k) number is K771032.

When did POUCHES, PEEL OPEN, BREATHABLE receive FDA 510(k) clearance?

POUCHES, PEEL OPEN, BREATHABLE received FDA 510(k) clearance on 1977-07-14, under 510(k) number K771032.

Who is the listed applicant for POUCHES, PEEL OPEN, BREATHABLE?

The FDA 510(k) record lists Surgicot, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POUCHES, PEEL OPEN, BREATHABLE?

The FDA product code for POUCHES, PEEL OPEN, BREATHABLE is FRG.

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Other records listing Surgicot, Inc. as applicant

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K962605PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERK863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854631ASSERT EO BIOLOGICAL TEST PACKK854902SURGICOT STEAM TEST PACK

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Related Devices (Code: FRG)

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K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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