The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for In-room And Sharpstar.
Device ID | K941991 |
510k Number | K941991 |
Device Name: | IN-ROOM AND SHARPSTAR |
Classification | Container, Sharps |
Applicant | SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
Contact | Gregory T Davis |
Correspondent | Gregory T Davis SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-25 |
Decision Date | 1994-08-29 |