SUNGLASSES— 510(k) K941084

Substantially Equivalent

Blue Gem Sunglasses, Inc.

FDA 510(k) clearance K941084 for SUNGLASSES, Substantially Equivalent on 1995-08-14. Applicant: Blue Gem Sunglasses, Inc..

Clearance details

Applicant: Blue Gem Sunglasses, Inc.
Product code: Code HQY
Advisory panel: Ophthalmic
Date received: 1994-03-08
Decision date: 1995-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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