The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Suction Catheters & Kits.
Device ID | K921851 |
510k Number | K921851 |
Device Name: | 4 SURE TM SUCTION CATHETERS & KITS |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
Contact | Randall Green |
Correspondent | Randall Green BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-17 |
Decision Date | 1993-07-07 |