The following data is part of a premarket notification filed by Gottfried Medical, Inc. with the FDA for Ensil Fabric.
| Device ID | K010675 |
| 510k Number | K010675 |
| Device Name: | ENSIL FABRIC |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | GOTTFRIED MEDICAL, INC. 4105 W. ALEXIS RD. Toledo, OH 43623 |
| Contact | Brent M Gottfried |
| Correspondent | Brent M Gottfried GOTTFRIED MEDICAL, INC. 4105 W. ALEXIS RD. Toledo, OH 43623 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G420710 | K010675 | 000 |
| G420701 | K010675 | 000 |