The following data is part of a premarket notification filed by Fulcrum Medical, Inc with the FDA for Fulaccess Model 1.0.
| Device ID | K101707 |
| 510k Number | K101707 |
| Device Name: | FULACCESS MODEL 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | FULCRUM MEDICAL, INC 17209 CHESTERFIELD AIRPORT ROA Chesterfield, MO 63005 |
| Contact | Scott Brame |
| Correspondent | Scott Brame FULCRUM MEDICAL, INC 17209 CHESTERFIELD AIRPORT ROA Chesterfield, MO 63005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863284000308 | K101707 | 000 |