The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Rica(tm)-ring Intest. Compress. Staple Anastom Kit.
Device ID | K873748 |
510k Number | K873748 |
Device Name: | RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT |
Classification | Staple, Implantable |
Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
Contact | Orofino |
Correspondent | Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-16 |
Decision Date | 1988-01-06 |