The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Smartstitch M-connector, Model Om-8700; Needle Cassette, Om-8750; Autocuff System Instrument Set, Om-9070.
Device ID | K033317 |
510k Number | K033317 |
Device Name: | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 |
Classification | Endoscopic Tissue Approximation Device |
Applicant | OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
Contact | Laura N Kasperowicz |
Correspondent | Laura N Kasperowicz OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
Product Code | OCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-15 |
Decision Date | 2003-12-30 |