FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENWOOD BIOLOGICAL STEOILIZ. INDICATOR
K Number: K771132
·
Decision Jul 14, 1977
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
202
Applicant Total
14
Review Days
21
Basic Information
- Device Name
- KENWOOD BIOLOGICAL STEOILIZ. INDICATOR
- K Number
- K771132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- WILL ROSS CO.
- Date Received
- June 23, 1977
- Decision Date
- July 14, 1977
- Product Code
- FRC
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by WILL ROSS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K780850 | SEARLE NEONATAL OXYGEN PROBE | Aug 23, 1978 | Substantially Equivalent |
| K771561 | DOVER URINE METER | Sep 7, 1977 | Substantially Equivalent |
| K770611 | PARALLEL BARS | Apr 8, 1977 | Substantially Equivalent |
| K770612 | SPLINT, BOHLER | Apr 8, 1977 | Substantially Equivalent |
| K770609 | TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT | Apr 8, 1977 | Substantially Equivalent |
| K770610 | TABLE, TREATMENT & TRACTION, HI-LO | Apr 8, 1977 | Substantially Equivalent |
| K770608 | WALKING AID | Apr 8, 1977 | Substantially Equivalent |
| K770607 | TRACTION HARNESS | Apr 8, 1977 | Substantially Equivalent |
| K770509 | TABLE, MASSAGE AND TREATMENT | Apr 5, 1977 | Substantially Equivalent |
| K770399 | VALVE FOR CLOSED SYS. URINARY DRAINAGE | Mar 9, 1977 | Substantially Equivalent |