The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Adhoc Claw.
Device ID | K023963 |
510k Number | K023963 |
Device Name: | ADHOC CLAW |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061 |
Contact | Steve Janin |
Correspondent | Steve Janin FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-29 |
Decision Date | 2003-05-05 |
Summary: | summary |