The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Continent Stoma System & Accessories.
Device ID | K844186 |
510k Number | K844186 |
Device Name: | CONTINENT STOMA SYSTEM & ACCESSORIES |
Classification | Trocar, Sinus |
Applicant | CHESEBROUGH-POND'S U.S.A. CO. P.O. BOX 6000 Greenwich, CT 06836 -6000 |
Contact | Arnold I Friede |
Correspondent | Arnold I Friede CHESEBROUGH-POND'S U.S.A. CO. P.O. BOX 6000 Greenwich, CT 06836 -6000 |
Product Code | KBG |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-29 |
Decision Date | 1985-01-15 |