The following data is part of a premarket notification filed by Spiracur, Inc. with the FDA for Cisnap Closed Incision System.
| Device ID | K133137 |
| 510k Number | K133137 |
| Device Name: | CISNAP CLOSED INCISION SYSTEM |
| Classification | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Applicant | SPIRACUR, INC. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Contact | Lori E Adels, Ph.d. |
| Correspondent | Lori E Adels, Ph.d. SPIRACUR, INC. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Product Code | OKO |
| CFR Regulation Number | 878.4683 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-10-11 |
| Decision Date | 2014-02-25 |
| Summary: | summary |