The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Feeding Tubes.
Device ID | K921853 |
510k Number | K921853 |
Device Name: | 4 SURE TM FEEDING TUBES |
Classification | Tubes, Gastrointestinal (and Accessories) |
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 | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-17 |
Decision Date | 1993-07-13 |