510(k) K821306
- Device
- HEAD-UP SUPINE SAFETY SUPPORT CUSHION
- Applicant
- MED-LIFE, INC.
- 510(k) number
- K821306
- Product code
- EPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-07
- Date received
- 1982-05-04
- Regulation
- 878.4950
- Classification name
- Support, Head, Surgical, Ent
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3018094310
- 3039435282
- 1045254
- 1926681
- 3018269545
- 3003790304
- 1928237
- 1643116
- 3011050570
- 3002858762
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EPW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K801326 | ANSPACH OPERATING TABLE SUPPORT/SPINAL | The Anspach Effort, Inc. | 1980-06-26 |
Legacy Summary#
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FDA Review#
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