FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IOP ADJUSTABLE STIRRUP
K Number: K884558
·
Decision Nov 17, 1988
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
19
Applicant Total
3
Review Days
17
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Basic Information
- Device Name
- IOP ADJUSTABLE STIRRUP
- K Number
- K884558
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mend Technologies, Inc.
- Date Received
- October 31, 1988
- Decision Date
- November 17, 1988
- Product Code
- BWN
- 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 |
|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | FDA class 1 | General, Plastic Surgery |
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