FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.
K Number: K871195
·
Decision Apr 6, 1987
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
2
Applicant Total
17
Review Days
13
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Basic Information
- Device Name
- MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.
- K Number
- K871195
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Military Engineering, Inc.
- Date Received
- March 24, 1987
- Decision Date
- April 6, 1987
- Product Code
- HXL
- 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 |
|---|---|---|---|
| HXL | Mallet | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXL), ordered by most recent decision date.
MALLET, SURGICAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROPLASTY MALLET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Military Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874335 | EXPLORER-DENTAL PROBER | Dec 29, 1987 | Substantially Equivalent |
| K873715 | BONE PIN CUTTER 18 | Oct 28, 1987 | Substantially Equivalent |
| K872842 | PIN, HIP, KNOWLES | Aug 7, 1987 | Substantially Equivalent |
| K871834 | DRILL, HAND, BONE, SMEDBERG | Jul 31, 1987 | Substantially Equivalent |
| K872091 | CURRETTES, ALVEOLAR (MOLT AND MILLER) | Jul 31, 1987 | Substantially Equivalent |
| K872738 | CORTICAL BONE SCREWS | Jul 30, 1987 | Substantially Equivalent |
| K872609 | CURETTE SET, ANTRUM, COAKLEY | Jul 15, 1987 | Substantially Equivalent |
| K871818 | SPATULA, DENTAL, CEMENT | Jul 2, 1987 | Substantially Equivalent |
| K872092 | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | Jun 23, 1987 | Substantially Equivalent |
| K870590 | CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY | Apr 16, 1987 | Substantially Equivalent |