510(k) K182090
- Device
- AposTherapy System
- Applicant
- APOS Medical Assets Ltd.
- 510(k) number
- K182090
- Product code
- QDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-16
- Date received
- 2018-08-02
- Regulation
- 890.3475
- Classification name
- Shoe With Adjustable Sole Units
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cliff Bleustein
- Address
- 7 Hapelech St. Tel Aviv IL 6816727 6816727
FDA Registration Numbers#
- 3029745680
- 3011404939
- 3033858295
- 3024753135
- 3035878914
- 3004784464
- 3031027442
Source Documents#
Legacy Summary#
summary
FDA Review#
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