Derm-A-Tec Skin Barrier Film
FDA 510(k) K822713 · Professional Medical Products, Inc.
510(k) numberK822713
Submission
- Device name
- Derm-A-Tec Skin Barrier Film
- Applicant
- Professional Medical Products, Inc.
Walker, MI, US - Received
- September 7, 1982
- Decision date
- December 7, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K862010 | Chick Surgical LightFTA · Traditional | 06/09/1986SE |
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| K834478 | Chick/Reison Patient Emerg. TrolleyKXJ · Traditional | 02/21/1984SE |
| K830825 | Yield Non-Adherent DressingFRO · Traditional | 05/13/1983SE |
| K820413 | Aegis Non-Adherent DressingNAB · Traditional | 03/12/1982SE |
Questions and answers
When was Derm-A-Tec Skin Barrier Film cleared by the FDA?
Derm-A-Tec Skin Barrier Film (K822713) received a 510(k) decision of Substantially Equivalent on December 7, 1982, 91 days after the submission was received.