Home / 510(k) Clearances / K853437

510(k) K853437

H-H HUNTER TENDON ROD by Holter-Hausner Intl.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
August 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Holter-Hausner Intl.

  • K875287 — H-H FLUSHING RESERVOIR (July 14, 1988)
  • K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG (January 19, 1988)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K871351 — H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP (May 14, 1987)
  • K870660 — H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS (May 1, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (January 13, 1987)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (October 16, 1985)
  • K853438 — H-H HUNTER ACTIVE TENDON IMPLANT (September 30, 1985)