The following data is part of a premarket notification filed by Safestitch Llc with the FDA for Amid Stapler.
Device ID | K093253 |
510k Number | K093253 |
Device Name: | AMID STAPLER |
Classification | Staple, Implantable |
Applicant | SAFESTITCH LLC 8282 SHADOW WOOD BLVD Coral Springs, FL 33071 |
Contact | Stewart Davis |
Correspondent | Stewart Davis SAFESTITCH LLC 8282 SHADOW WOOD BLVD Coral Springs, FL 33071 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-16 |
Decision Date | 2009-11-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AMID STAPLER 77760127 3846248 Dead/Cancelled |
SafeStitch Medical, Inc. 2009-06-15 |