The following data is part of a premarket notification filed by Devon Medical Products, Inc. with the FDA for Nature's Bond 600 And Nature's Bond 603.
| Device ID | K142168 |
| 510k Number | K142168 |
| Device Name: | NATURE'S BOND 600 AND NATURE'S BOND 603 |
| Classification | Pump, Breast, Powered |
| Applicant | DEVON MEDICAL PRODUCTS, INC. 1100 FIRST AVENUE, SUITE 202 King Of Prussia, PA 19406 |
| Contact | Ruth Wu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2014-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879766003597 | K142168 | 000 |
| 00810113681641 | K142168 | 000 |