The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Intravision(tm) Arthroscope System (add'l Appli.).
Device ID | K892376 |
510k Number | K892376 |
Device Name: | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) |
Classification | Arthroscope |
Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
Contact | Martha C Miller |
Correspondent | Martha C Miller CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-05 |
Decision Date | 1989-08-01 |