INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17— 510(k) K872607

Name: FDA 510(k) clearance K872607
Creator: U.S. Food and Drug Administration
Published: 1987-10-05

Substantially Equivalent

Randolph Engineering, Inc.

FDA 510(k) clearance K872607 for INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17, Substantially Equivalent on 1987-10-05. Applicant: Randolph Engineering, Inc.. Device class: 1.

Clearance details

Applicant: Randolph Engineering, Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1987-07-06
Decision date: 1987-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

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Recent devices under product code HQZ

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K952597 — VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW1995-09-12
K944313 — SPECTACLE FRAME1995-03-28
K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES1994-12-15
K945392 — SPECTACLE FRAME1994-12-15
K945770 — OPTICAL FRAMES1994-12-15

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