The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Corporation Tennis Racquet Insert.
| Device ID | K993522 |
| 510k Number | K993522 |
| Device Name: | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Joan Zacharopoulos |
| Correspondent | Joan Zacharopoulos AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365522120 | K993522 | 000 |
| B36511218L0 | K993522 | 000 |
| B365112180 | K993522 | 000 |
| B36511216S0 | K993522 | 000 |
| B365112160 | K993522 | 000 |
| B365112060 | K993522 | 000 |
| B365112050 | K993522 | 000 |
| B365562910 | K993522 | 000 |
| B36511218LS0 | K993522 | 000 |