The following data is part of a premarket notification filed by Whittlestone, Inc. with the FDA for Whittlestone Breastpump.
Device ID | K002696 |
510k Number | K002696 |
Device Name: | WHITTLESTONE BREASTPUMP |
Classification | Pump, Breast, Powered |
Applicant | WHITTLESTONE, INC. 601A STONE RD. Benicia, CA 94510 |
Contact | Bruce Mckendry |
Correspondent | Bruce Mckendry WHITTLESTONE, INC. 601A 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 | 2000-08-30 |
Decision Date | 2001-03-21 |