FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONE LAVAGE SYSTEM
K Number: K926337
·
Decision Jun 11, 1993
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
2
Review Days
176
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Basic Information
- Device Name
- BONE LAVAGE SYSTEM
- K Number
- K926337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Surgical Devices Corp.
- Date Received
- December 17, 1992
- Decision Date
- June 11, 1993
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
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Other Clearances by Innovative Surgical Devices Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K884404 | HERNIASTAT | Nov 8, 1988 | Substantially Equivalent |