The following data is part of a premarket notification filed by Spiracur, Inc. with the FDA for Snap Wound Care System.
| Device ID | K142272 |
| 510k Number | K142272 |
| Device Name: | SNaP Wound Care System |
| Classification | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Applicant | SPIRACUR, INC. 1180 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Contact | Lawrence Hu |
| Correspondent | Ronald S. Warren EXPERIEN GROUP, LLC 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 | No |
| Date Received | 2014-08-15 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554005570 | K142272 | 000 |
| 00849554005563 | K142272 | 000 |
| 00849554005549 | K142272 | 000 |