The following data is part of a premarket notification filed by European Custom Manufacturing Bv with the FDA for Fastlock, Model Pc175m01, Pc175mce, Pc005r01.
| Device ID | K080621 |
| 510k Number | K080621 |
| Device Name: | FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | EUROPEAN CUSTOM MANUFACTURING BV 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose EUROPEAN CUSTOM MANUFACTURING BV 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-04-29 |
| Summary: | summary |