The following data is part of a premarket notification filed by Opus Ksd, Inc. with the FDA for Subq It! Bioabsorbable Skin Closure System.
| Device ID | K131563 |
| 510k Number | K131563 |
| Device Name: | SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM |
| Classification | Staple, Implantable |
| Applicant | OPUS KSD, INC. 62 Forest Street Suite 300 Marlborough, MA 01752 |
| Contact | Rosina Robinson, Rn, Med, Rac |
| Correspondent | Rosina Robinson, Rn, Med, Rac OPUS KSD, INC. 62 Forest Street Suite 300 Marlborough, MA 01752 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-30 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867469000206 | K131563 | 000 |
| 10867469000210 | K131563 | 000 |
| 10867469000227 | K131563 | 000 |