FDA 510(k)

DRAPES, BARRIER, STERILE PATIENT READY

K-Number: K760212 · 1976-08-11

Decision Date1976-08-11

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DRAPES, BARRIER, STERILE PATIENT READY is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1976-08-11 under 510(k) number K760212. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAPES, BARRIER, STERILE PATIENT READY?

DRAPES, BARRIER, STERILE PATIENT READY is a medical device that received FDA 510(k) clearance on 1976-08-11. The listed applicant is Surgikos, Inc.. The 510(k) number is K760212.

When did DRAPES, BARRIER, STERILE PATIENT READY receive FDA 510(k) clearance?

DRAPES, BARRIER, STERILE PATIENT READY received FDA 510(k) clearance on 1976-08-11, under 510(k) number K760212.

Who is the listed applicant for DRAPES, BARRIER, STERILE PATIENT READY?

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

What is the FDA product code for DRAPES, BARRIER, STERILE PATIENT READY?

The FDA product code for DRAPES, BARRIER, STERILE PATIENT READY is KKX.

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Other records listing Surgikos, Inc. as applicant

K875107HEALTH CARE EYE PROTECTION K874653STERILE SURGICAL SCRUB BRUSH K861441NEUTRALON SURGICAL GLOVES K852870BARRIER SURGICAL GOWN K822535CIDEX*DIALYZER DISINFECTING SOLUTION K820543BARRIER ANTIMICROBIAL INCISE DRAPE

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Related Devices (Code: KKX)

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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.