The following data is part of a premarket notification filed by Pureway Compliance, Inc with the FDA for Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon.
| Device ID | K151249 |
| 510k Number | K151249 |
| Device Name: | PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON |
| Classification | Container, Sharps |
| Applicant | PUREWAY COMPLIANCE, INC 201 SANTA MONICA BLVD. SUITE 400 Santa Monica, CA 90401 |
| Contact | Jeffery Miglicco |
| Correspondent | Jeffery Miglicco PUREWAY COMPLIANCE, INC 201 SANTA MONICA BLVD. SUITE 400 Santa Monica, CA 90401 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-12 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853022008123 | K151249 | 000 |
| 10853022008021 | K151249 | 000 |
| 10853022008038 | K151249 | 000 |
| 10853022008045 | K151249 | 000 |
| 10853022008052 | K151249 | 000 |
| 10853022008069 | K151249 | 000 |
| 10853022008076 | K151249 | 000 |
| 10853022008083 | K151249 | 000 |
| 10853022008090 | K151249 | 000 |
| 00853022008109 | K151249 | 000 |
| 00853022008116 | K151249 | 000 |
| 10853022008014 | K151249 | 000 |