The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Genie' Single Ceiling And Double Ceiling.
| Device ID | K963682 |
| 510k Number | K963682 |
| Device Name: | GENIE' SINGLE CEILING AND DOUBLE CEILING |
| Classification | Light, Surgical, Ceiling Mounted |
| 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 | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858480006162 | K963682 | 000 |
| 00858480006155 | K963682 | 000 |
| 00858480006148 | K963682 | 000 |
| 00858480006124 | K963682 | 000 |
| 00858480006117 | K963682 | 000 |