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510(k) K941399

OPERATING MICROSCOPE AA OM 10 by Appasamy Associates (U.S.A.), Inc. — Product Code FSO

K941399 is an FDA 510(k) premarket notification submitted by Appasamy Associates (U.S.A.), Inc. for the device "OPERATING MICROSCOPE AA OM 10". The FDA issued a decision of Substantially Equivalent on April 22, 1994. The device falls under product code FSO (Microscope, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1994
Date Received
March 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances for product code FSO

  • K942304 — MICROFLEX (June 13, 1994)
  • K920689 — DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM (November 12, 1993)
  • K926288 — SOM 6VI (SURGICAL OPERATING MICROSCOPE) (October 12, 1993)
  • K931303 — WOODLYN OPERATION MICROSCOPE (June 25, 1993)
  • K926513 — MOLLER-WEDEL OPERATING MICROSCOPE (June 22, 1993)
  • K910357 — SOM 6V (February 19, 1991)
  • K902076 — J2 MICROSCOPE (August 1, 1990)
  • K874241 — OPMI MD SURGICAL MICROSCOPE (December 23, 1987)
  • K822562 — ODONTO-SCOPE (October 6, 1982)
  • K822181 — BINOCULAR OPER. MICROSCOPES & ACCESSOR (August 27, 1982)

FDA data resources