The following data is part of a premarket notification filed by Protomed Corp. with the FDA for Protomed/towic Nasogastric Tube Drainage Bag.
Device ID | K841986 |
510k Number | K841986 |
Device Name: | PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | PROTOMED CORP. 830 TANNERY DRIVE Wayne , PA 19087 - |
Contact | Towic Medical |
Correspondent | Towic Medical PROTOMED CORP. 830 TANNERY DRIVE Wayne , PA 19087 - |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-15 |
Decision Date | 1984-09-10 |