The following data is part of a premarket notification filed by Bissell Medical Products, Inc. with the FDA for Nyhus/nelson Tube.
Device ID | K851672 |
510k Number | K851672 |
Device Name: | NYHUS/NELSON TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | BISSELL MEDICAL PRODUCTS, INC. 135 SOUTH LASALLE ST. Chicago, IL 60603 |
Contact | Thomas R Meites |
Correspondent | Thomas R Meites BISSELL MEDICAL PRODUCTS, INC. 135 SOUTH LASALLE ST. Chicago, IL 60603 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-23 |
Decision Date | 1985-07-09 |