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510(k) K791280

OPERATION MICROSCOPE SOM 1 by Elmed, Inc. — Product Code FSO

K791280 is an FDA 510(k) premarket notification submitted by Elmed, Inc. for the device "OPERATION MICROSCOPE SOM 1". The FDA issued a decision of Substantially Equivalent on July 24, 1979. The device falls under product code FSO (Microscope, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4700. Elmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
July 10, 1979
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 by Elmed, Inc.

  • K010465 — DENSTAT (May 14, 2001)
  • K974793 — ELMED ESU 120 M/M DIGITAL (March 19, 1998)
  • K953271 — ELMED RF-ALERT (January 18, 1996)
  • K952110 — ELMED THERMO-FLUX (August 14, 1995)
  • K926517 — ELMED LBC 50-P (November 15, 1994)
  • K932938 — ELMED ESU 300 M/M AND DIGITAL (May 2, 1994)
  • K921770 — ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M (May 17, 1993)
  • K915731 — ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL (November 5, 1992)
  • K905417 — ELMED PNEUMOMAT DIGITAL (January 31, 1991)
  • K881431 — SIEMENS STEREODYNATOR 828 (April 16, 1990)

Other clearances for product code FSO

  • K942304 — MICROFLEX (June 13, 1994)
  • K941399 — OPERATING MICROSCOPE AA OM 10 (April 22, 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)

FDA data resources