The following data is part of a premarket notification filed by Safestich Medical, Llc with the FDA for Amid Stapler.
Device ID | K120268 |
510k Number | K120268 |
Device Name: | AMID STAPLER |
Classification | Staple, Implantable |
Applicant | SAFESTICH MEDICAL, LLC 4400 BISCAYNE BLVD. SUITE 670 Miami, FL 33137 |
Contact | Alina Caraballo |
Correspondent | Alina Caraballo SAFESTICH MEDICAL, LLC 4400 BISCAYNE BLVD. SUITE 670 Miami, FL 33137 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-30 |
Decision Date | 2012-02-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AMID STAPLER 77760127 3846248 Dead/Cancelled |
SafeStitch Medical, Inc. 2009-06-15 |