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510(k) K831912

ROUND-BEEHIVE- DISSECTORS 3/8 by Ormed Mfg., Inc. — Product Code GDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
June 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dissector, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ormed Mfg., Inc.

  • K931555 — ARTROMOT K2 CPM (January 31, 1994)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880909 — TRACHEOTOMY SPONGES (March 17, 1988)
  • K880851 — FLAT STICK SPONGE (March 17, 1988)
  • K880911 — BLUNT SPONGE (March 17, 1988)

Other clearances for product code GDI

  • K896383 — DISPOSABLE EXTERNAL CLAMPS (December 6, 1989)
  • K850288 — HEPATIC PARENCHYMAL SUCTION DISSECTOR (March 18, 1985)
  • K822569 — TYMPANOPLASTY & SKIN DISSECTORS (October 6, 1982)
  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)
  • K791703 — TEW BYPASS INSTRUMENTS & DISSECTING KIT (October 4, 1979)