FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
H-H HUNTER PASSIVE TENDON IMPLANT
K Number: K853436
·
Decision Oct 16, 1985
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
3
Applicant Total
42
Review Days
62
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Basic Information
- Device Name
- H-H HUNTER PASSIVE TENDON IMPLANT
- K Number
- K853436
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Holter-Hausner Intl.
- Date Received
- August 15, 1985
- Decision Date
- October 16, 1985
- Product Code
- HXR
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HXR | Spatula, Orthopedic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXR), ordered by most recent decision date.
MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
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FDA Class 1
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VIDEO ARTHROSCOPE, 1.7MM X 55 MM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RAYLOR FUSION FUNNEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K853437 | H-H HUNTER TENDON ROD | Oct 16, 1985 | Substantially Equivalent |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Sep 30, 1985 | Substantially Equivalent for Some Indications |