The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Conveen Leg Bag Strap.
Device ID | K953783 |
510k Number | K953783 |
Device Name: | CONVEEN LEG BAG STRAP |
Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
Contact | Mary Lee Lewis |
Correspondent | Mary Lee Lewis COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
Product Code | FAQ |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-14 |
Decision Date | 1995-09-13 |