FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
K Number: K885019
·
Decision Jan 25, 1989
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
12
Review Days
57
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Basic Information
- Device Name
- BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
- K Number
- K885019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bemis Health Care
- Date Received
- November 29, 1988
- Decision Date
- January 25, 1989
- 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 Bemis Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K822557 | SPECIMEN ADAPTOR | Oct 18, 1982 | Substantially Equivalent |
| K822556 | CRITICAL MEASUREMENT UNIT | Oct 18, 1982 | Substantially Equivalent |
| K803206 | SUCTION PROBE | Jan 21, 1981 | Substantially Equivalent |
| K771737 | SUCTION CANISTER | Dec 20, 1977 | Substantially Equivalent |
| K771738 | MALE URINAL | Sep 28, 1977 | Substantially Equivalent |
| K771733 | 8 EMESIS BASIN | Sep 28, 1977 | Substantially Equivalent |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | Aug 23, 1976 | Substantially Equivalent |
| K760071 | TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 | Jul 20, 1976 | Substantially Equivalent |
| K760070 | TUMBLER, PERSONAL, ROUND, 9 OUNCE | Jul 20, 1976 | Substantially Equivalent |
| K760073 | BASIN, WASH, 6-QT RECTANGULAR | Jul 20, 1976 | Substantially Equivalent |