The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Alm Surgical Lamps.
Device ID | K882613 |
510k Number | K882613 |
Device Name: | ALM SURGICAL LAMPS |
Classification | Lamp, Surgical |
Applicant | ALM SURGICAL EQUIPMENT, INC. 30 NORTH RAYMOND AVE. STE. 305 Pasadena, CA 91103 |
Contact | A, Young |
Correspondent | A, Young ALM SURGICAL EQUIPMENT, INC. 30 NORTH RAYMOND AVE. STE. 305 Pasadena, CA 91103 |
Product Code | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-24 |
Decision Date | 1988-07-18 |