The following data is part of a premarket notification filed by Corpak, Inc. with the FDA for Clog Zapper Enteral Feeding Tube Declogging System.
Device ID | K970178 |
510k Number | K970178 |
Device Name: | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CORPAK, INC. 100 CHADDICK DR. Wheeling, IL 60090 |
Contact | Robert E Booth |
Correspondent | Robert E Booth CORPAK, INC. 100 CHADDICK DR. Wheeling, IL 60090 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-17 |
Decision Date | 1997-07-21 |