510(k) Premarket Notification

• Device Classification Name: apparatus, autotransfusion
• 510(k) Number: K893394
• Device Name: ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
• Applicant: HAEMONETICS CORP.; 400 WOOD RD.; P.O. BOX 9114; BRAINTREE, MA 02184
• Applicant Contact: MICHAEL MATHEWS
• Correspondent: HAEMONETICS CORP.; 400 WOOD RD.; P.O. BOX 9114; BRAINTREE, MA 02184
• Correspondent Contact: MICHAEL MATHEWS
• Regulation Number: 868.5830
• Classification Product Code: CAC
• Date Received: 05/01/1989
• Decision Date: 10/19/1989
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Anesthesiology
• 510k Review Panel: Anesthesiology
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No