The following data is part of a premarket notification filed by Olive Medical Corp. with the FDA for Ovs1 Video System.
Device ID | K123359 |
510k Number | K123359 |
Device Name: | OVS1 VIDEO SYSTEM |
Classification | Light Source, Fiberoptic, Routine |
Applicant | OLIVE MEDICAL CORP. 2302 Presidents Dr Ste D Salt Lake City, UT 84120 |
Contact | Brian Dean |
Correspondent | Brian Dean OLIVE MEDICAL CORP. 2302 Presidents Dr Ste D Salt Lake City, UT 84120 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-31 |
Decision Date | 2012-12-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705028702 | K123359 | 000 |