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510(k) K920689

DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM by Deemed, Inc. — Product Code FSO

K920689 is an FDA 510(k) premarket notification submitted by Deemed, Inc. for the device "DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 12, 1993. 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
November 12, 1993
Date Received
February 14, 1992
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)
  • K941399 — OPERATING MICROSCOPE AA OM 10 (April 22, 1994)
  • 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