Geneva Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 6
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K881217 | GENT-L-KARE STERILE URINARY LEG BAG | July 29, 1988 |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | July 28, 1988 |
| K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER | July 28, 1988 |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | June 7, 1988 |
| K861308 | ACCUPAC CUSTOM PACK KERLIX SQUARES | May 2, 1986 |
| K861219 | ACCUPAC CUSTOM SKIN SCRUB KIT | April 15, 1986 |
| K853265 | ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 | August 26, 1985 |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | May 24, 1985 |
| K844255 | GENT-L-KARE STERILE I.V. START KIT | December 19, 1984 |
| K843090 | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM | December 4, 1984 |
| K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM | April 27, 1983 |
| K822735 | SURE-COUNT DISPOSABLE NEEDLE COUNTER | March 9, 1983 |
| K802940 | SUPER-SPIKE TRANSFER SET | January 15, 1981 |