The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Powerpro Pneumatic System, Models Pro6150, Pro6175, Pro6185.
| Device ID | K032607 |
| 510k Number | K032607 |
| Device Name: | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 |
| Classification | Drill, Bone, Powered |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura Krejci |
| Correspondent | Laura Krejci LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | DZI |
| Subsequent Product Code | HBB |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2003-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854028388 | K032607 | 000 |
| 30845854036208 | K032607 | 000 |
| 30845854036192 | K032607 | 000 |
| 30845854028630 | K032607 | 000 |