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FDA 510(k)

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)

K-Number: K962605 · 1997-03-11

ApplicantSurgicot, Inc.
Decision Date1997-03-11
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K962605. 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 PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)?

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Surgicot, Inc.. The 510(k) number is K962605.

When did PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) receive FDA 510(k) clearance?

PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) received FDA 510(k) clearance on 1997-03-11, under 510(k) number K962605.

Who is the listed applicant for PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)?

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 PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)?

The FDA product code for PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) is FRG.

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Other records listing Surgicot, Inc. as applicant

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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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