The following data is part of a premarket notification filed by Spiracur, Inc. with the FDA for Snap Wound Care System.
| Device ID | K132080 |
| 510k Number | K132080 |
| Device Name: | SNAP WOUND CARE SYSTEM |
| Classification | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Applicant | SPIRACUR, INC. 755 N. MATHILDA AVENUE Sunnyvale, CA 94085 |
| Contact | Sarah L Canio |
| Correspondent | Sarah L Canio SPIRACUR, INC. 755 N. MATHILDA AVENUE 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 | 2013-07-05 |
| Decision Date | 2014-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554006362 | K132080 | 000 |
| 00849554005419 | K132080 | 000 |
| 00849554005402 | K132080 | 000 |