The following data is part of a premarket notification filed by A & A Medical, Inc. with the FDA for Tom Cat F.l., Tom Cat S.l..
| Device ID | K972245 |
| 510k Number | K972245 |
| Device Name: | TOM CAT F.L., TOM CAT S.L. |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | A & A MEDICAL, INC. 4100 NINE MCFARLAND DR., #B Alpharetta, GA 30201 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-08-06 |
| Summary: | summary |