The following data is part of a premarket notification filed by Sensormed with the FDA for Cablecap Model: Wlf, Stz, Acm.
Device ID | K101496 |
510k Number | K101496 |
Device Name: | CABLECAP MODEL: WLF, STZ, ACM |
Classification | Light, Surgical, Fiberoptic |
Applicant | SENSORMED 2450 EJ CHAPMAN DR., SUITE 104 Knoxville, TN 37996 |
Contact | William Milam |
Correspondent | William Milam SENSORMED 2450 EJ CHAPMAN DR., SUITE 104 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 | 2010-06-01 |
Decision Date | 2010-09-14 |
Summary: | summary |