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510(k) K915057

CANN-HOLD by O.R. Concepts, Inc. — Product Code KGX

K915057 is an FDA 510(k) premarket notification submitted by O.R. Concepts, Inc. for the device "CANN-HOLD". The FDA issued a decision of Substantially Equivalent on March 19, 1992. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. O.R. Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1992
Date Received
November 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by O.R. Concepts, Inc.

  • K941337 — FLOWGUN ELECTROCAUTERY PROBES (August 17, 1994)
  • K935971 — FLOWGUN ELECTROCAUTERY PROBES (May 16, 1994)
  • K935970 — FLOWGUN ELECTROCAUTERY PROBE HANDLE (May 16, 1994)
  • K935645 — FLOWGUN REUSABLE IRRIGATION PROBES (March 7, 1994)
  • K926242 — ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE (October 15, 1993)
  • K922244 — INSUFFLATOR TUBING/FILTER KIT (September 24, 1993)
  • K922197 — INSUFFLATOR TUBING KIT (September 24, 1993)
  • K932449 — DR. FOG (August 11, 1993)
  • K925147 — ORC 10.0MM SUCTION PROBE (June 25, 1993)
  • K925024 — ORC TAPPERED IRRIGATING PROBE (May 21, 1993)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources