The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Integrated Drive/pump System.
Device ID | K981636 |
510k Number | K981636 |
Device Name: | INTEGRATED DRIVE/PUMP SYSTEM |
Classification | Arthroscope |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Carol A Weideman |
Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-08 |
Decision Date | 1998-08-20 |
Summary: | summary |