Cleared Traditional

K954308 - GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
(FDA 510(k) Clearance)

K954308 · Gamp & Assoc. · Ophthalmic

Dec 1995

Decision

98d

Days

Class 2

Risk

K954308 is an FDA 510(k) clearance for the GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE. This device is classified as a Photocoagulator And Accessories (Class II — Special Controls, product code HQB).

Submitted by Gamp & Assoc. (Chesterfield, US). The FDA issued a Cleared decision on December 22, 1995, 98 days after receiving the submission on September 15, 1995.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number	K954308 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 1995
Decision Date	December 22, 1995
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement