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FDA 510(k)

SHIRT, MITTEN CUFF INFANT

K-Number: K760360 · 1976-10-20

ApplicantPrecept, Inc.
Decision Date1976-10-20
Product CodeFME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHIRT, MITTEN CUFF INFANT is the device name listed in this FDA 510(k) record. The listed applicant is Precept, Inc.. It received FDA 510(k) clearance on 1976-10-20 under 510(k) number K760360. The device is classified under product code FME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIRT, MITTEN CUFF INFANT?

SHIRT, MITTEN CUFF INFANT is a medical device that received FDA 510(k) clearance on 1976-10-20. The listed applicant is Precept, Inc.. The 510(k) number is K760360.

When did SHIRT, MITTEN CUFF INFANT receive FDA 510(k) clearance?

SHIRT, MITTEN CUFF INFANT received FDA 510(k) clearance on 1976-10-20, under 510(k) number K760360.

Who is the listed applicant for SHIRT, MITTEN CUFF INFANT?

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

What is the FDA product code for SHIRT, MITTEN CUFF INFANT?

The FDA product code for SHIRT, MITTEN CUFF INFANT is FME.

Related Clinical Trials

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Other records listing Precept, 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.

K771409DISP. SURGICAL FACE MASKK770463MASK, SURGICAL, FACE, DISPOSABLEK770391COVER, ARMBOARD, DISPOSABLEK770021MASK, FACE, SURGICAL

Related Devices (Code: FME)

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.

K880385KIMBERLY-CLARK PROFESSIONAL JACKETKimberly-Clark Corp.K811915MONITOR/VITAL SIGNS TRAYAmerican Hospital Supply Corp.K770476EXAM GOWNGeneral Medical Co.K760954CROWNTEX EXAM. CAPE & GOWNGraham Manufacturing Co.

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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