The following data is part of a premarket notification filed by Medical Specifics, Inc. with the FDA for Model 8800 Aspirator.
| Device ID | K963775 |
| 510k Number | K963775 |
| Device Name: | MODEL 8800 ASPIRATOR |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDICAL SPECIFICS, INC. 3306 WILEY POST RD., SUITE 106 Carrollton, TX 75006 |
| Contact | Howard Chilton |
| Correspondent | Howard Chilton MEDICAL SPECIFICS, INC. 3306 WILEY POST RD., SUITE 106 Carrollton, TX 75006 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-19 |
| Decision Date | 1997-03-26 |