510(k) K950889
- Device
- ADEL 5000
- Applicant
- STRYKER CORP.
- 510(k) number
- K950889
- Product code
- HDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-16
- Date received
- 1995-02-28
- Regulation
- 884.4900
- Classification name
- Table, Obstetrical, Ac-powered (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHAD A COBERLY
- Address
- 420 Alcott St. Kalamazoo MI US 49001 49001
FDA Registration Numbers#
- 3008058231
- 3033433849
- 3005987240
- 3007031002
- 3011919098
- 3027847726
- 3015136704
- 3043654660
- 1831750
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | Hill-Rom, Inc. | 1992-04-20 |
| K875123 | ORCEPAD | Alton Dean Medical, Inc. | 1988-06-21 |
| K874610 | ADEL MODEL 2100 BIRTHING BED | Adel Medical , Ltd. | 1988-01-21 |
| K810886 | ADEL MEDICAL BIRTHING BED, #LD-500 | Adel Medical , Ltd. | 1981-04-23 |
| K771942 | TILT 10, CATALOG #S-2600 | Affiliated Hospital Products, Inc. | 1977-10-27 |
| K770438 | CART, PROCEDURES | I E Industries | 1977-07-01 |
Legacy Summary#
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FDA Review#
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