Clearance Summary
VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 received FDA 510(k) clearance under submission number K924835, sponsored by American Healthcare Supply Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-03-23.
- Submission: K924835
- Applicant / Sponsor: American Healthcare Supply Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1993-03-23
Classification & Regulation
This clearance is catalogued under FDA product code MCZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.