The following data is part of a premarket notification filed by Whittlestone, Inc. with the FDA for Whittlestone Expresser.
| Device ID | K051112 |
| 510k Number | K051112 |
| Device Name: | WHITTLESTONE EXPRESSER |
| Classification | Pump, Breast, Powered |
| Applicant | WHITTLESTONE, INC. 602 B STONE RD. Benicia, CA 94510 |
| Contact | Bruce Mckendry |
| Correspondent | Bruce Mckendry WHITTLESTONE, INC. 602 B STONE RD. Benicia, CA 94510 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-02 |
| Decision Date | 2005-09-07 |