FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRYKER ECLIPSE WARMING STRETCHER
K Number: K912237
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
1
Applicant Total
14
Review Days
70
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Basic Information
- Device Name
- STRYKER ECLIPSE WARMING STRETCHER
- K Number
- K912237
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stryker Medical
- Date Received
- May 21, 1991
- Decision Date
- July 30, 1991
- Product Code
- DWI
- 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 |
|---|---|---|---|
| DWI | Saw, Electrically Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWI), ordered by most recent decision date.
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