The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Fastforward.
Device ID | K141420 |
510k Number | K141420 |
Device Name: | FASTFORWARD |
Classification | Washer, Bolt Nut |
Applicant | MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta, GA 30318 |
Contact | Jeremy Blair |
Correspondent | Jeremy Blair MEDSHAPE, INC 1575 NORTHSIDE DRIVE, SUITE 440 Atlanta, GA 30318 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-29 |
Decision Date | 2014-12-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860003755525 | K141420 | 000 |
00860003755518 | K141420 | 000 |
00860003755532 | K141420 | 000 |