FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PROCEDURE KIT
K Number: K926269
·
Decision Aug 27, 1993
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
15
Review Days
252
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Basic Information
- Device Name
- PROCEDURE KIT
- K Number
- K926269
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- General Medical Co.
- Date Received
- December 18, 1992
- Decision Date
- August 27, 1993
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by General Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K912975 | OPERAND LUBRICATING JELLY | Sep 27, 1991 | Substantially Equivalent |
| K912132 | OPERAND LUBRICATING JELLY | Aug 7, 1991 | Substantially Equivalent |
| K903669 | GENESIS INSUFFLATING CATHETER | Sep 12, 1990 | Substantially Equivalent |
| K900110 | OPERAND* LUBRICATING JELLY | May 2, 1990 | Substantially Equivalent |
| K853635 | SUBDERM TM | Dec 20, 1985 | Substantially Equivalent |
| K844652 | C.A.S.E. CONTAINER | Dec 12, 1984 | Substantially Equivalent |
| K831320 | DRIONIC | Jul 19, 1983 | Substantially Equivalent |
| K820689 | C.S.R. WRAPPERS | Apr 9, 1982 | Substantially Equivalent |
| K820521 | STERILIZATION WRAP | Mar 18, 1982 | Substantially Equivalent |
| K802231 | AIR VIVA II | Oct 10, 1980 | Substantially Equivalent |