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 |