The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Surgical Laser Accessories (sla) Case.
Device ID | K862629 |
510k Number | K862629 |
Device Name: | SURGICAL LASER ACCESSORIES (SLA) CASE |
Classification | Tray, Surgical, Instrument |
Applicant | SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
Contact | Robert A Basye |
Correspondent | Robert A Basye SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-10 |
Decision Date | 1986-07-17 |