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510(k) K831340

DRAIN-R-DRAPE(EYE by Sur-Tech, Inc. — Product Code HMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 25, 1983
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 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)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K854613 — SURGICAL DRAPES, OPHTHALMIN (February 13, 1986)
  • K830822 — EYE DRAPE (April 6, 1983)