FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
K Number: K951811
·
Decision May 31, 1995
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
24
Review Days
42
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Basic Information
- Device Name
- OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
- K Number
- K951811
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteotech, Inc.
- Date Received
- April 19, 1995
- Decision Date
- May 31, 1995
- Product Code
- LRP
- 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 |
|---|---|---|---|
| LRP | Tray, Surgical | FDA class 1 | General, Plastic Surgery |
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