The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Hematome System.
| Device ID | K885066 |
| 510k Number | K885066 |
| Device Name: | HEMATOME SYSTEM |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | SURGICAL DYNAMICS, INC. 650 WHITNEY ST. San Leandro, CA 94577 |
| Contact | Ronald Allen |
| Correspondent | Ronald Allen SURGICAL DYNAMICS, INC. 650 WHITNEY ST. San Leandro, CA 94577 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-06 |
| Decision Date | 1989-05-01 |