The following data is part of a premarket notification filed by Moss Tubes, Inc. with the FDA for Modification Of Moss P.e.g. Tray.
Device ID | K984628 |
510k Number | K984628 |
Device Name: | MODIFICATION OF MOSS P.E.G. TRAY |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MOSS TUBES, INC. 304 VERONA AVE. Elizabeth, NJ 07208 |
Contact | Harry Schlakman |
Correspondent | Harry Schlakman MOSS TUBES, INC. 304 VERONA AVE. Elizabeth, NJ 07208 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-30 |
Decision Date | 1999-03-17 |