The following data is part of a premarket notification filed by Nova Design Technologies, Ltd. with the FDA for Tube Declogger.
| Device ID | K905164 |
| 510k Number | K905164 |
| Device Name: | TUBE DECLOGGER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | NOVA DESIGN TECHNOLOGIES, LTD. 19 EAST CENTRAL AVE. Paoli, PA 19301 |
| Contact | Andrew J Milligan |
| Correspondent | Andrew J Milligan NOVA DESIGN TECHNOLOGIES, LTD. 19 EAST CENTRAL AVE. Paoli, PA 19301 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-16 |
| Decision Date | 1991-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859911004405 | K905164 | 000 |
| 00859911004252 | K905164 | 000 |
| 00859911004245 | K905164 | 000 |
| 00859911004238 | K905164 | 000 |
| 00859911004221 | K905164 | 000 |
| 08599110040058 | K905164 | 000 |
| 08599110040041 | K905164 | 000 |
| 08599110040034 | K905164 | 000 |
| 08599110040027 | K905164 | 000 |
| 00859911004269 | K905164 | 000 |
| 20612479260058 | K905164 | 000 |
| 20612479260072 | K905164 | 000 |
| 00859911004344 | K905164 | 000 |
| 00859911004337 | K905164 | 000 |
| 00859911004320 | K905164 | 000 |
| 00859911004313 | K905164 | 000 |
| 00859911004306 | K905164 | 000 |
| 20612479260133 | K905164 | 000 |
| 20612479260119 | K905164 | 000 |
| 20612479260096 | K905164 | 000 |
| 08599110040010 | K905164 | 000 |