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FDA 510(k)

MULTIPLE, SURGICAL DRAPE PACK

K-Number: K911132 · 1991-05-06

ApplicantCentral Georgia Ancillary Health Systems
Decision Date1991-05-06
Product CodeFZI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIPLE, SURGICAL DRAPE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Central Georgia Ancillary Health Systems. It received FDA 510(k) clearance on 1991-05-06 under 510(k) number K911132. The device is classified under product code FZI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE, SURGICAL DRAPE PACK?

MULTIPLE, SURGICAL DRAPE PACK is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Central Georgia Ancillary Health Systems. The 510(k) number is K911132.

When did MULTIPLE, SURGICAL DRAPE PACK receive FDA 510(k) clearance?

MULTIPLE, SURGICAL DRAPE PACK received FDA 510(k) clearance on 1991-05-06, under 510(k) number K911132.

Who is the listed applicant for MULTIPLE, SURGICAL DRAPE PACK?

The FDA 510(k) record lists Central Georgia Ancillary Health Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE, SURGICAL DRAPE PACK?

The FDA product code for MULTIPLE, SURGICAL DRAPE PACK is FZI.

Related Clinical Trials

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.

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Other records listing Central Georgia Ancillary Health Systems 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.

K923798SURGICAL GOWN PACKK911131STERILE SURGICAL GOWN PACK

Related Devices (Code: FZI)

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.

K910468STERILE DISPOSABLE DRAPE(S)E.M. AdamsK854159ELLIPTI-PUNCHAlcon LaboratoriesK772395DAVIS RHYTIDECTOMYEdward Weck, Inc.K772394KALRN FACE-LIFE SCISSORSEdward Weck, 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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