The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Safety Screw Connector.
Device ID | K113719 |
510k Number | K113719 |
Device Name: | SAFETY SCREW CONNECTOR |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | ABBOTT LABORATORIES 3300 STELZER ROAD Columbus, OH 43219 -3034 |
Contact | Elizabeth M Zola |
Correspondent | Elizabeth M Zola ABBOTT LABORATORIES 3300 STELZER ROAD Columbus, OH 43219 -3034 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-19 |
Decision Date | 2012-04-20 |
Summary: | summary |