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510(k) K871706

OPTHA PREP by Treace Medical, Inc. — Product Code HMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1987
Date Received
May 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Patient, Ophthalmic
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)
  • K870763 — SUPER SCISSORS (March 18, 1987)

Other clearances for product code HMT

  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K872620 — SOLOS EYESITE DRAPES (July 31, 1987)
  • K854613 — SURGICAL DRAPES, OPHTHALMIN (February 13, 1986)
  • K831340 — DRAIN-R-DRAPE(EYE (June 8, 1983)
  • K830822 — EYE DRAPE (April 6, 1983)