FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-PREP CEMENT RESTRICTOR
K Number: K931847
·
Decision Jun 28, 1994
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
7
Review Days
441
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Basic Information
- Device Name
- BIO-PREP CEMENT RESTRICTOR
- K Number
- K931847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomedical Devices, Inc.
- Date Received
- April 13, 1993
- Decision Date
- June 28, 1994
- Product Code
- LZN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Biomedical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955439 | THE REEL THING (MODIFICATION) | Dec 26, 1995 | Substantially Equivalent |
| K931846 | BIO-PREP | Jan 21, 1994 | Substantially Equivalent |
| K925982 | BMD AIR/OXYGEN BLENDER | Oct 7, 1993 | Substantially Equivalent |
| K903533 | STERI-SHIELD | Oct 19, 1990 | Substantially Equivalent |
| K902677 | STERI-SHIELD | Aug 17, 1990 | Substantially Equivalent |
| K830605 | PUMP PALL AMBULATORY INSULIN INFUSION | Mar 31, 1983 | Substantially Equivalent |