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510(k) K864897

DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 by Dale Medical Products, Inc. — Product Code GAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 15, 1986
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

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  • K894586 — DALE I.V. IDENTIFIER; PRODUCT #1125 (August 15, 1989)
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  • K860583 — DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 (February 21, 1986)

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)
  • K853472 — FINGER TOURNIQUETTE (October 10, 1985)
  • K853537 — VELCRO TOURNIQUET (September 12, 1985)
  • K852277 — CATAPRESS TOURNIGUET (June 27, 1985)
  • K851482 — TOURNIQUET (April 29, 1985)