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510(k) K936050

JAW SPREADER by Gam Industries, Inc. — Product Code KBW

K936050 is an FDA 510(k) premarket notification submitted by Gam Industries, Inc. for the device "JAW SPREADER". The FDA issued a decision of Substantially Equivalent on March 24, 1994. The device falls under product code KBW (Screw, Oral), a Class I device regulated under 21 CFR 874.4420. Gam Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Oral
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Gam Industries, Inc.

  • K941641 — DISPOSABLE EMERGENCY OBSTETRICAL KIT (October 3, 1994)
  • K941336 — COMBO MASK (September 9, 1994)
  • K942021 — MOUTH TO MOUTH BREATHER (June 22, 1994)
  • K930401 — ALUMINUM FOIL (May 12, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K915569 — UMBILICAL CLAMP (September 23, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)

FDA data resources