The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Adel 5000.
| Device ID | K950889 |
| 510k Number | K950889 |
| Device Name: | ADEL 5000 |
| Classification | Table, Obstetrical, Ac-powered (and Accessories) |
| Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 -6197 |
| Contact | Chad A Coberly |
| Correspondent | Chad A Coberly STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 -6197 |
| Product Code | HDD |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327278163 | K950889 | 000 |
| 07613327278095 | K950889 | 000 |
| 07613327175387 | K950889 | 000 |
| 07613327175233 | K950889 | 000 |
| 07613327175196 | K950889 | 000 |
| 07613327175189 | K950889 | 000 |
| 07613327175172 | K950889 | 000 |
| 07613327175165 | K950889 | 000 |