510(k) K912237
- Device
- STRYKER ECLIPSE WARMING STRETCHER
- Applicant
- STRYKER MEDICAL
- 510(k) number
- K912237
- Product code
- DWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-30
- Date received
- 1991-05-21
- Regulation
- 878.4820
- Classification name
- Saw, Electrically Powered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID JOHNSON
- Address
- 6300 S. Sprinkle Rd. Kalamazoo MI US 49001 49001
FDA Registration Numbers#
- 1422375
- 3003800209
- 3012494290
- 1836161
- 8010697
- 9610612
- 3015972835
- 8040278
- 3043148563
- 1055890
- 8010704
- 9611253
- 3043088060
- 8043496
- 9611112
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K801914 | TEMP STERNUM SAW | Temp Medical Products, Inc. | 1980-10-23 |
Legacy Summary#
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FDA Review#
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