The following data is part of a premarket notification filed by Cdc Products Corp. with the FDA for Emergency-clean Up(tm) Ecp.
Device ID | K880306 |
510k Number | K880306 |
Device Name: | EMERGENCY-CLEAN UP(TM) ECP |
Classification | Collector, Ostomy |
Applicant | CDC PRODUCTS CORP. 23-23 BORDEN AVE. Long Island City, NY 11101 |
Contact | Jayne Drobbin |
Correspondent | Jayne Drobbin CDC PRODUCTS CORP. 23-23 BORDEN AVE. Long Island City, NY 11101 |
Product Code | EXB |
CFR Regulation Number | 876.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-25 |
Decision Date | 1988-05-20 |