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
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
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 | Jul 14, 1988 | Substantially Equivalent |
| K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG | Jan 19, 1988 | Substantially Equivalent |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP | May 14, 1987 | Substantially Equivalent |
| K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS | May 1, 1987 | Substantially Equivalent |
| K865075 | H-H SUBGALEAL TROCAR | Jan 13, 1987 | Substantially Equivalent |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Oct 16, 1985 | Substantially Equivalent |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Sep 30, 1985 | Substantially Equivalent for Some Indications |