The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Nasogastric Bridle System With Magnetic Retrieval.
Device ID | K030784 |
510k Number | K030784 |
Device Name: | NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
Contact | Chris Zantopulos |
Correspondent | Chris Zantopulos APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-12 |
Decision Date | 2004-04-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842071131098 | K030784 | 000 |
00842071106683 | K030784 | 000 |
00842071111502 | K030784 | 000 |
00842071111519 | K030784 | 000 |
00842071111526 | K030784 | 000 |
00842071111533 | K030784 | 000 |
00842071111540 | K030784 | 000 |
00842071111557 | K030784 | 000 |
00842071111564 | K030784 | 000 |
00842071106676 | K030784 | 000 |
00842071106669 | K030784 | 000 |
00842071131104 | K030784 | 000 |
00842071131111 | K030784 | 000 |
00842071106607 | K030784 | 000 |
00842071106614 | K030784 | 000 |
00842071106621 | K030784 | 000 |
00842071106638 | K030784 | 000 |
00842071106645 | K030784 | 000 |
00842071106652 | K030784 | 000 |
00842071111571 | K030784 | 000 |
00842071111588 | K030784 | 000 |
00842071115906 | K030784 | 000 |
00842071118136 | K030784 | 000 |
00842071118280 | K030784 | 000 |
00842071118297 | K030784 | 000 |
00842071118303 | K030784 | 000 |
00842071118310 | K030784 | 000 |
00842071118327 | K030784 | 000 |
00842071118334 | K030784 | 000 |
00842071119546 | K030784 | 000 |
00842071118266 | K030784 | 000 |
00842071118259 | K030784 | 000 |
00842071115913 | K030784 | 000 |
00842071115920 | K030784 | 000 |
00842071115937 | K030784 | 000 |
00842071118204 | K030784 | 000 |
00842071118211 | K030784 | 000 |
00842071118228 | K030784 | 000 |
00842071118235 | K030784 | 000 |
00842071118242 | K030784 | 000 |
00842071119553 | K030784 | 000 |