510(k) K801326
- Device
- ANSPACH OPERATING TABLE SUPPORT/SPINAL
- Applicant
- THE ANSPACH EFFORT, INC.
- 510(k) number
- K801326
- Product code
- EPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-26
- Date received
- 1980-06-03
- 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#
- 1643116
- 3018269545
- 1928237
- 3039435282
- 3002858762
- 3018094310
- 1926681
- 3011050570
- 1045254
- 3003790304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EPW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K821306 | HEAD-UP SUPINE SAFETY SUPPORT CUSHION | Med-Life, Inc. | 1982-06-07 |
Legacy Summary#
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FDA Review#
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