The following data is part of a premarket notification filed by Bissell Medical Products, Inc. with the FDA for Grassi Gastrojejun Tube Gastric Decomp/jejun Feed.
Device ID | K914140 |
510k Number | K914140 |
Device Name: | GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED |
Classification | Stretcher, Hand-carried |
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 | FPP |
CFR Regulation Number | 880.6900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-16 |
Decision Date | 1992-03-31 |