Home / 510(k) Clearances / K854613

510(k) K854613

SURGICAL DRAPES, OPHTHALMIN by Charles Atkins & Co. — Product Code HMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1986
Date Received
November 18, 1985
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 Charles Atkins & Co.

  • K853759 — CUSTOM PROCEDURAL TRAY PROCEDURAL KIT (November 17, 1985)

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)
  • K831340 — DRAIN-R-DRAPE(EYE (June 8, 1983)
  • K830822 — EYE DRAPE (April 6, 1983)