FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE REMOVAL KIT
K Number: K761193
·
Decision Jan 12, 1977
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
15
Review Days
37
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Basic Information
- Device Name
- SUTURE REMOVAL KIT
- K Number
- K761193
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Superior Plastic Products Corp.
- Date Received
- December 6, 1976
- Decision Date
- January 12, 1977
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Superior Plastic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851981 | NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. | Jun 18, 1985 | Substantially Equivalent |
| K843975 | 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE | Nov 20, 1984 | Substantially Equivalent |
| K841945 | ENTERAL FEEDING BOTTLE | Jul 26, 1984 | Substantially Equivalent |
| K841630 | ENTERAL NUTRITION PUMP | Jun 7, 1984 | Substantially Equivalent |
| K840324 | SILICONE SUMP DRAIN 20 & 40 FRENCH | Apr 25, 1984 | Substantially Equivalent |
| K840323 | SILICONE SUCTION & IRRIGATION DRAIN | Apr 25, 1984 | Substantially Equivalent |
| K841480 | INFECTION CONTROL VALVE | Apr 25, 1984 | Substantially Equivalent |
| K833687 | DISPOS. ENTERIC FEEDING TUBES W/SAFE-T | Mar 2, 1984 | Substantially Equivalent |
| K833947 | SUPERIOR ENTERNAL FEEDING SYSTEM | Feb 4, 1984 | Substantially Equivalent |
| K820460 | 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION | Mar 8, 1982 | Substantially Equivalent |