The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Para-pro Fc50.
| Device ID | K053257 |
| 510k Number | K053257 |
| Device Name: | PARA-PRO FC50 |
| Classification | Device, Parasite Concentration |
| Applicant | ALPHA-TEC SYSTEMS, INC. 12019 N.E. 99TH ST., #1780 Vancouver, WA 98682 |
| Contact | Richard Williams |
| Correspondent | Richard Williams ALPHA-TEC SYSTEMS, INC. 12019 N.E. 99TH ST., #1780 Vancouver, WA 98682 |
| Product Code | LKS |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2006-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085023656 | K053257 | 000 |