The following data is part of a premarket notification filed by Innovative Medical Design Corp. with the FDA for Nasograstric Tubbe Holder.
Device ID | K922209 |
510k Number | K922209 |
Device Name: | NASOGRASTRIC TUBBE HOLDER |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | INNOVATIVE MEDICAL DESIGN CORP. 1322 ROBIN LN. Bayside, NY 11360 |
Contact | Henry J Alletto |
Correspondent | Henry J Alletto INNOVATIVE MEDICAL DESIGN CORP. 1322 ROBIN LN. Bayside, NY 11360 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-12 |
Decision Date | 1992-10-30 |