The following data is part of a premarket notification filed by Benson Medical Instruments Co. with the FDA for Benson Cca100.
| Device ID | K924652 |
| 510k Number | K924652 |
| Device Name: | BENSON CCA100 |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | BENSON MEDICAL INSTRUMENTS CO. 137 CECIL ST. SE Minneapolis, MN 55414 |
| Contact | David P Mayou |
| Correspondent | David P Mayou BENSON MEDICAL INSTRUMENTS CO. 137 CECIL ST. SE Minneapolis, MN 55414 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-15 |
| Decision Date | 1993-04-09 |