The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Alm Prismalix (prx) Surgical Light.
| Device ID | K982063 |
| 510k Number | K982063 |
| Device Name: | ALM PRISMALIX (PRX) SURGICAL LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Contact | Susan Nielsen |
| Correspondent | Susan Nielsen ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-12 |
| Decision Date | 1998-09-22 |
| Summary: | summary |