FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILIZATION WRAP
K Number: K820521
·
Decision Mar 18, 1982
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- STERILIZATION WRAP
- K Number
- K820521
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- General Medical Co.
- Date Received
- February 26, 1982
- Decision Date
- March 18, 1982
- Product Code
- FRG
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by General Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K926269 | PROCEDURE KIT | Aug 27, 1993 | Unknown |
| 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 |
| K802231 | AIR VIVA II | Oct 10, 1980 | Substantially Equivalent |