The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Mucus Specimen Trap.
Device ID | K962168 |
510k Number | K962168 |
Device Name: | MUCUS SPECIMEN TRAP |
Classification | Bottle, Collection, Vacuum |
Applicant | SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
Contact | Karen Pinto |
Correspondent | Karen Pinto SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-05 |
Decision Date | 1996-07-22 |