FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALTRAC(R) INTRODUCER FORCEP
K Number: K922348
·
Decision Jun 9, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
7
Review Days
21
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Basic Information
- Device Name
- VALTRAC(R) INTRODUCER FORCEP
- K Number
- K922348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Cyanamid Co.
- Date Received
- May 19, 1992
- Decision Date
- June 9, 1992
- Product Code
- HJE
- 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 |
|---|---|---|---|
| HJE | Lamp, Fluorescein, Ac-Powered | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HJE), ordered by most recent decision date.
FLUORESCENT SUN LAMP FIXTURE
FDA 510(k)
FDA Class 2
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EXAMINER 10
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by American Cyanamid Co.
| K Number | Device Name | ||
|---|---|---|---|
| K930992 | FLEXON AND STAINLESS STEEL SUTURES | Dec 17, 1993 | Substantially Equivalent |
| K931056 | DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING | Jul 8, 1993 | Substantially Equivalent |
| K921696 | CUTTING AND COAGULATION DEVICES AND ACCESSORIES | Nov 18, 1992 | Substantially Equivalent |
| K900198 | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | Jul 5, 1990 | Substantially Equivalent for Some Indications |
| K896946 | COATED NOVAFIL, POLYBUTESTER, MESH | May 7, 1990 | Substantially Equivalent |
| K823552 | APPOSE SKIN STAPLER & REMOVER | Jun 15, 1983 | Substantially Equivalent |