The following data is part of a premarket notification filed by Mmi, Inc. with the FDA for Clamp-n-cut.
Device ID | K860445 |
510k Number | K860445 |
Device Name: | CLAMP-N-CUT |
Classification | Clamp, Umbilical |
Applicant | MMI, INC. 19500 WEST EIGHT MILE RD. P.O. BOX 305 Southfield, MI 48037 |
Contact | Mattler |
Correspondent | Mattler MMI, INC. 19500 WEST EIGHT MILE RD. P.O. BOX 305 Southfield, MI 48037 |
Product Code | HFW |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-04 |
Decision Date | 1986-04-04 |