Cleared Traditional

CLAYMAN-PAREL CAPSULE COUPEUR

K841101 · Miami Eye Technology, Inc. · Ophthalmic
May 1984
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K841101 is an FDA 510(k) clearance for the CLAYMAN-PAREL CAPSULE COUPEUR, a Cystotome (Class I — General Controls, product code HNY), submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1984, 64 days after receiving the submission on March 13, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K841101 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 1984
Decision Date May 16, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNY — Cystotome
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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