The following data is part of a premarket notification filed by Surcraft Llc. with the FDA for Solo Band Ligator.
Device ID | K960020 |
510k Number | K960020 |
Device Name: | SOLO BAND LIGATOR |
Classification | Ligator, Hemorrhoidal |
Applicant | SURCRAFT LLC. PLAZA ONE 12368 WARWICK BLVD. Newport News, VA 23606 |
Contact | Jacobus Budding |
Correspondent | Jacobus Budding SURCRAFT LLC. PLAZA ONE 12368 WARWICK BLVD. Newport News, VA 23606 |
Product Code | FHN |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-02 |
Decision Date | 1996-04-01 |
Summary: | summary |