The following data is part of a premarket notification filed by Cox Family Laboratories, Inc. with the FDA for Odor-safe(tm)(liquid) Odor-safe(tm) Powder.
Device ID | K871526 |
510k Number | K871526 |
Device Name: | ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER |
Classification | Collector, Ostomy |
Applicant | COX FAMILY LABORATORIES, INC. P.O. BOX 175 Lynden, WA 98264 |
Contact | James P Cox |
Correspondent | James P Cox COX FAMILY LABORATORIES, INC. P.O. BOX 175 Lynden, WA 98264 |
Product Code | EXB |
CFR Regulation Number | 876.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-20 |
Decision Date | 1987-10-13 |