Surgiform Augmentation Material (S.F.A.M.)
FDA 510(k) K021889 · Surgical Technology Laboratories, Inc.
510(k) numberK021889
Submission
- Device name
- Surgiform Augmentation Material (S.F.A.M.)
- Applicant
- Surgical Technology Laboratories, Inc.
Cleveland, OH, US - Received
- June 7, 2002
- Decision date
- October 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3500
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Surgiform Augmentation Material (S.F.A.M.) cleared by the FDA?
Surgiform Augmentation Material (S.F.A.M.) (K021889) received a 510(k) decision of Substantially Equivalent on October 16, 2002, 131 days after the submission was received.
What is the product code of K021889?
The FDA product code is KKY – Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, a Class II (moderate risk) device regulated under 21 CFR 878.3500.