FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
K Number: K881378
·
Decision Jun 17, 1988
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
7
Applicant Total
30
Review Days
77
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Basic Information
- Device Name
- PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
- K Number
- K881378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Pfizer, Inc.
- Date Received
- April 1, 1988
- Decision Date
- June 17, 1988
- Product Code
- LXI
- 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 |
|---|---|---|---|
| LXI | Guide, Drill, Ligament | FDA class 1 | General, Plastic Surgery |
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