The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Basic, Median, Dominant, And Vario.
| Device ID | K983552 |
| 510k Number | K983552 |
| Device Name: | BASIC, MEDIAN, DOMINANT, AND VARIO |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 Mchenry, IL 60050 -7005 |
| Contact | Stephen D Smith |
| Correspondent | Stephen D Smith MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 Mchenry, IL 60050 -7005 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1999-01-07 |