FDA 510(k) Application Details - K241355

Device Classification Name	More FDA Info for this Device
510(K) Number	K241355
Device Name	SER Pen Carain MicroSystem (MP1209SP)
Applicant	Su-Ko Technologies LLC 700 Smith Street, #61070 Houston, TX 77002 US Other 510(k) Applications for this Company
Contact	Yuan Yuan "Susie" Su Korrodi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2024
Decision Date	10/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review