The following data is part of a premarket notification filed by Bissell Medical Products, Inc. with the FDA for Grassi Gastrojejunostomy Tube.
Device ID | K932880 |
510k Number | K932880 |
Device Name: | GRASSI GASTROJEJUNOSTOMY TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | BISSELL MEDICAL PRODUCTS, INC. 608 SOUTH WASHINGTON ST. # 201 Naperville, IL 60540 |
Contact | Sharyl A Dewane |
Correspondent | Sharyl A Dewane BISSELL MEDICAL PRODUCTS, INC. 608 SOUTH WASHINGTON ST. # 201 Naperville, IL 60540 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-14 |
Decision Date | 1995-06-07 |