The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Irrigation System.
Device ID | K961192 |
510k Number | K961192 |
Device Name: | IRRIGATION SYSTEM |
Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Carol A Weiderman |
Correspondent | Carol A Weiderman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Product Code | ERL |
CFR Regulation Number | 874.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-26 |
Decision Date | 1996-04-26 |