The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Micropower Hand Piece High Speed Drill.
Device ID | K060260 |
510k Number | K060260 |
Device Name: | MICROPOWER HAND PIECE HIGH SPEED DRILL |
Classification | Motor, Drill, Electric |
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 | HBC |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-01 |
Decision Date | 2006-04-10 |
Summary: | summary |