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FDA 510(k)

SURGIPEEL SELF-SEAL PACKAGING SYSTEM

K-Number: K820302 · 1982-02-24

ApplicantSurgicot, Inc.
Decision Date1982-02-24
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGIPEEL SELF-SEAL PACKAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1982-02-24 under 510(k) number K820302. 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 SURGIPEEL SELF-SEAL PACKAGING SYSTEM?

SURGIPEEL SELF-SEAL PACKAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1982-02-24. The listed applicant is Surgicot, Inc.. The 510(k) number is K820302.

When did SURGIPEEL SELF-SEAL PACKAGING SYSTEM receive FDA 510(k) clearance?

SURGIPEEL SELF-SEAL PACKAGING SYSTEM received FDA 510(k) clearance on 1982-02-24, under 510(k) number K820302.

Who is the listed applicant for SURGIPEEL SELF-SEAL PACKAGING SYSTEM?

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 SURGIPEEL SELF-SEAL PACKAGING SYSTEM?

The FDA product code for SURGIPEEL SELF-SEAL PACKAGING SYSTEM is FRG.

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Other records listing Surgicot, Inc. 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.

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)

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.

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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