FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATH CARE KIT
K Number: K760560
·
Decision Nov 12, 1976
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
11
Review Days
71
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Basic Information
- Device Name
- CATH CARE KIT
- K Number
- K760560
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Walpak Co.
- Date Received
- September 2, 1976
- Decision Date
- November 12, 1976
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Walpak Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803200 | IRRIGATION SET W/BULB SYRINGE | Jan 21, 1981 | Substantially Equivalent |
| K803204 | IRRIGATION PISTON | Jan 21, 1981 | Substantially Equivalent |
| K803199 | SUTURE REMOVAL KIT | Jan 15, 1981 | Substantially Equivalent |
| K803198 | IRRIGATION SET W/PISTON SYRINGE | Jan 15, 1981 | Substantially Equivalent |
| K803201 | LEMON GLYCERINE SWABS | Dec 17, 1980 | Unknown |
| K802083 | CATHETER INSERTION TRAY | Sep 16, 1980 | Substantially Equivalent |
| K791598 | CLOSED SYSTEM FOLEY CATHERIZATION PROCED | Nov 16, 1979 | Substantially Equivalent |
| K780123 | CATHETERIZATION PROCEDURE TRAY | Feb 21, 1978 | Substantially Equivalent |
| K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL | Feb 21, 1978 | Substantially Equivalent |
| K770446 | SPONGES, LAPAROTOMY | Jun 15, 1977 | Substantially Equivalent |