Cleared Traditional

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100

K870806 · United Surgical Corp. · Ophthalmic
Mar 1987
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K870806 is an FDA 510(k) clearance for the NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by United Surgical Corp. (Irvine, US). The FDA issued a Cleared decision on March 26, 1987, 28 days after receiving the submission on February 26, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K870806 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1987
Decision Date March 26, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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