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510(k) K843056

ELASTIC BANDAGE by Sterile Medical Systems — Product Code GAX

K843056 is an FDA 510(k) premarket notification submitted by Sterile Medical Systems for the device "ELASTIC BANDAGE". The FDA issued a decision of Substantially Equivalent on December 4, 1984. The device falls under product code GAX (Tourniquet, Nonpneumatic), a Class I device regulated under 21 CFR 878.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1984
Date Received
August 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Nonpneumatic
Device Class
Class I
Regulation Number
878.5900
Review Panel
SU
Submission Type

Other clearances for product code GAX

  • K931198 — UNIQUET (September 1, 1993)
  • K881398 — TOURNIQUET (April 29, 1988)
  • K881176 — STERILE ESMARCH BANDAGE (April 11, 1988)
  • K875092 — DEGANIA SILICONE TOURNIQUET (January 7, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K872003 — KINDERWRAP (June 23, 1987)
  • K864897 — DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (January 12, 1987)
  • K853472 — FINGER TOURNIQUETTE (October 10, 1985)
  • K853537 — VELCRO TOURNIQUET (September 12, 1985)
  • K852277 — CATAPRESS TOURNIGUET (June 27, 1985)

FDA data resources