510(k) K884787
- Device
- ACCULITE-PPL 5
- Applicant
- MEDICAL ALIGNMENT SYSTEMS
- 510(k) number
- K884787
- Product code
- INE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-24
- Date received
- 1988-11-15
- Regulation
- 890.3910
- Classification name
- Sling, Overhead Suspension, Wheelchair
- Medical specialty
- Physical Medicine
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH S STOUT
- Address
- 9160 S. 300 W., Bldg. 1, Ste19 Sandy UT US 84070 84070
FDA Registration Numbers#
- 3010472212
- 3009491742
- 3010865451
- 3018269545
- 3033790380
- 3007441619
- 3018229265
- 1041130
- 3002734713
- 8022890
- 3011497619
- 3014200467
- 2438690
- 3004108325
- 3013530901
- 3006358931
- 3009513998
- 3008720499
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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