The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Amset Pld System.
Device ID | K905014 |
510k Number | K905014 |
Device Name: | AMSET PLD SYSTEM |
Classification | Arthroscope |
Applicant | ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
Contact | Ronald C Allen |
Correspondent | Ronald C Allen ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-06 |
Decision Date | 1991-04-01 |