The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Gastrostomy Tube.
Device ID | K931921 |
510k Number | K931921 |
Device Name: | CORPAK GASTROSTOMY TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 |
Contact | Robert E Booth |
Correspondent | Robert E Booth CORPAK CO. 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 | 1993-04-16 |
Decision Date | 1995-06-09 |