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FDA 510(k)

SURGICLEAN ENZYMATIC INSTRUMENT CLEANER

K-Number: K931270 · 1994-04-13

ApplicantSurgicot, Inc.
Decision Date1994-04-13
Product CodeFLG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICLEAN ENZYMATIC INSTRUMENT CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1994-04-13 under 510(k) number K931270. The device is classified under product code FLG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICLEAN ENZYMATIC INSTRUMENT CLEANER?

SURGICLEAN ENZYMATIC INSTRUMENT CLEANER is a medical device that received FDA 510(k) clearance on 1994-04-13. The listed applicant is Surgicot, Inc.. The 510(k) number is K931270.

When did SURGICLEAN ENZYMATIC INSTRUMENT CLEANER receive FDA 510(k) clearance?

SURGICLEAN ENZYMATIC INSTRUMENT CLEANER received FDA 510(k) clearance on 1994-04-13, under 510(k) number K931270.

Who is the listed applicant for SURGICLEAN ENZYMATIC INSTRUMENT CLEANER?

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 SURGICLEAN ENZYMATIC INSTRUMENT CLEANER?

The FDA product code for SURGICLEAN ENZYMATIC INSTRUMENT CLEANER is FLG.

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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)K863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854631ASSERT EO BIOLOGICAL TEST PACKK854902SURGICOT STEAM TEST PACKK840541NEURO SPONGE

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Related Devices (Code: FLG)

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.

K944950KLENZYMECalgon Corp.K944494ALSA-KLENZCalgon Vestal Div.K944033BILL EVANS-KLENZCalgon Vestal Div.K940263NPH-KLENZCalgon Corp.K941163MON-KLENZCalgon Vestal Div.K935063INSTRU KLENZCalgon 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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