The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Devilbiss Model 6305d Heavy Duty Ac Aspirator.
| Device ID | K981602 |
| 510k Number | K981602 |
| Device Name: | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Allan R Jones |
| Correspondent | Allan R Jones SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-05 |
| Decision Date | 1998-07-17 |
| Summary: | summary |