The following data is part of a premarket notification filed by Sensormed with the FDA for Cablecap.
Device ID | K113330 |
510k Number | K113330 |
Device Name: | CABLECAP |
Classification | Light, Surgical, Fiberoptic |
Applicant | SENSORMED 2450 EJ CHAPMAN DR., Knoxville, TN 37996 |
Contact | William Milam |
Correspondent | William Milam SENSORMED 2450 EJ CHAPMAN DR., Knoxville, TN 37996 |
Product Code | FST |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-14 |
Decision Date | 2012-01-12 |
Summary: | summary |