The following data is part of a premarket notification filed by Professional Disposables International, Inc. with the FDA for Prevantics Device Swab.
| Device ID | K132380 |
| 510k Number | K132380 |
| Device Name: | PREVANTICS DEVICE SWAB |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. 2 NICE PAK PARK Orangeburg, NY 10962 |
| Contact | Elizabeth Ernst |
| Correspondent | Elizabeth Ernst PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. 2 NICE PAK PARK Orangeburg, NY 10962 |
| Product Code | LKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-31 |
| Decision Date | 2014-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00310819001779 | K132380 | 000 |
| 10310819001523 | K132380 | 000 |
| 00310819000031 | K132380 | 000 |