SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)— 510(k) K872015

Name: FDA 510(k) clearance K872015
Creator: U.S. Food and Drug Administration
Published: 1987-06-17

Substantially Equivalent

Brigam, Inc.

FDA 510(k) clearance K872015 for SPIRASEAL(TM) FACE MASK (VARIOUS SIZES), Substantially Equivalent on 1987-06-17. Applicant: Brigam, Inc.. Device class: 1.

Clearance details

Applicant: Brigam, Inc.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1987-05-26
Decision date: 1987-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morganton, NC, US

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K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK1995-07-11
K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK1995-06-07

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