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FDA 510(k)

ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543

K-Number: K853265 · 1985-08-26

ApplicantGeneva Laboratories, Inc.
Decision Date1985-08-26
Product Code
DecisionSubstantially Equivalent

Device Summary

ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1985-08-26 under 510(k) number K853265. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543?

ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 is a medical device that received FDA 510(k) clearance on 1985-08-26. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K853265.

When did ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 receive FDA 510(k) clearance?

ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 received FDA 510(k) clearance on 1985-08-26, under 510(k) number K853265.

Who is the listed applicant for ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543?

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

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Other records listing Geneva Laboratories, 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.

K881217GENT-L-KARE STERILE URINARY LEG BAGK881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERK881218GENT-L-KARE CLEANSING ENEMA SETK881216GENT-L-KARE VAGINAL IRRIGATION SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KIT

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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.

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