The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Genesis.
Device ID | K942553 |
510k Number | K942553 |
Device Name: | GENESIS |
Classification | Lamp, Surgical |
Applicant | BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
Contact | Gretel Lumley |
Correspondent | Gretel Lumley BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
Product Code | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-31 |
Decision Date | 1994-06-23 |