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510(k) K852934

PRECISION - COSMET CAPSULE COUPEUR by Precision-Cosmet Co., Inc. — Product Code HNY

K852934 is an FDA 510(k) premarket notification submitted by Precision-Cosmet Co., Inc. for the device "PRECISION - COSMET CAPSULE COUPEUR". The FDA issued a decision of Substantially Equivalent on August 8, 1985. The device falls under product code HNY (Cystotome), a Class I device regulated under 21 CFR 886.4350. Precision-Cosmet Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystotome
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Precision-Cosmet Co., Inc.

  • K861057 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (April 24, 1986)
  • K840204 — WHITE OCULAR PRESSURE RELIEF DEVICE (February 15, 1985)
  • K840104 — PETRUS IOL GUIDE (April 24, 1984)

Other clearances for product code HNY

  • K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPU (May 16, 1996)
  • K880345 — CYSTOTOMES/KNIFES (May 3, 1988)
  • K875001 — PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (April 13, 1988)
  • K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (April 13, 1988)
  • K874997 — PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (April 13, 1988)
  • K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (April 13, 1988)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K871365 — CAPSULECTOMER CYSTOTOME (April 16, 1987)

FDA data resources