SHIRT, MITTEN CUFF INFANT— 510(k) K760360

Substantially Equivalent

Precept, Inc.

FDA 510(k) clearance K760360 for SHIRT, MITTEN CUFF INFANT, Substantially Equivalent on 1976-10-20. Applicant: Precept, Inc.. Device class: 1.

Clearance details

Applicant: Precept, Inc.
Product code: Code FME
Device class: Class 1
Regulation: 21 CFR 880.6265
Advisory panel: General Hospital
Date received: 1976-08-02
Decision date: 1976-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FME

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K770476 — EXAM GOWN1977-05-06
K760954 — CROWNTEX EXAM. CAPE & GOWN1976-12-30

More clearances from Precept, Inc.

K771409 — DISP. SURGICAL FACE MASK1977-10-27
K770463 — MASK, SURGICAL, FACE, DISPOSABLE1977-03-23
K770391 — COVER, ARMBOARD, DISPOSABLE1977-03-07
K770021 — MASK, FACE, SURGICAL1977-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.