The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery(r) Tapered Safe-t-tube(tm).
Device ID | K903876 |
510k Number | K903876 |
Device Name: | MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
Contact | Stuart K Montgomery |
Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-22 |
Decision Date | 1991-02-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EBES7213100 | K903876 | 000 |
EBES7210080 | K903876 | 000 |
34063107101633 | K903876 | 000 |
34063107101626 | K903876 | 000 |