The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, And Oscillating Saw.
| Device ID | K060198 |
| 510k Number | K060198 |
| Device Name: | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW |
| Classification | Arthroscope |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-26 |
| Decision Date | 2006-05-11 |
| Summary: | summary |