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510(k) K831936

PRE-ROLLED TUBULAR STOCKINETTE by Ormed Mfg., Inc.

K831936 is an FDA 510(k) premarket notification submitted by Ormed Mfg., Inc. for the device "PRE-ROLLED TUBULAR STOCKINETTE". The FDA issued a decision of Substantially Equivalent on December 30, 1983. Ormed Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1983
Date Received
June 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Ormed Mfg., Inc.

  • K931555 — ARTROMOT K2 CPM (January 31, 1994)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K880851 — FLAT STICK SPONGE (March 17, 1988)
  • K880909 — TRACHEOTOMY SPONGES (March 17, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880852 — ROSEBUD DISSECTORS (March 17, 1988)

FDA data resources