The following data is part of a premarket notification filed by Bellhouse Medical, Inc. with the FDA for Multi-strip.
Device ID | K901228 |
510k Number | K901228 |
Device Name: | MULTI-STRIP |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | BELLHOUSE MEDICAL, INC. 2933 MANNING AVENUE NORTH Lake Elmo, MN 55042 |
Contact | Julia Jackson |
Correspondent | Julia Jackson BELLHOUSE MEDICAL, INC. 2933 MANNING AVENUE NORTH Lake Elmo, MN 55042 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-14 |
Decision Date | 1990-05-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MULTI-STRIP 74062993 1678975 Dead/Cancelled |
BELLINGHAM MEDICAL, INC. 1990-05-29 |
MULTI-STRIP 72253719 0837132 Dead/Expired |
BOWES "SEAL FAST" CORPORATION 1966-09-02 |
MULTI-STRIP 72235292 0834484 Dead/Expired |
W. L. GORE & ASSOCIATES, INC. 1965-12-27 |