FDA 510(k) Substantially Equivalent 🇺🇸 United States

H-H HUNTER TENDON ROD

K Number: K853437 · Decision Oct 16, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
42
Review Days
62

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Basic Information

Device Name
H-H HUNTER TENDON ROD
K Number
K853437
Clearance Type
Traditional
Decision
Substantially Equivalent
Applicant
Holter-Hausner Intl.
Date Received
August 15, 1985
Decision Date
October 16, 1985
Advisory Committee
Unknown
Review Advisory Committee
OR
Third Party
N

Other Clearances by Holter-Hausner Intl.

K Number Device Name
K875287 H-H FLUSHING RESERVOIR
K874508 H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K872285 H-H HUNTER ACTIVE TENDON IMPLANT DC
K872284 H-H HUNTER ACTIVE TENDON IMPLANT PC
K872293 H-H HUNTER ACTIVE TENDON IMPLANT BC
K871351 H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K870660 H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
K865075 H-H SUBGALEAL TROCAR
K853436 H-H HUNTER PASSIVE TENDON IMPLANT
K853438 H-H HUNTER ACTIVE TENDON IMPLANT
Search all 42 clearances from Holter-Hausner Intl. →