FDA 510(k) K912702, PLASTIC ATTACHABLE DUAL PORT, by Davol, Inc.

FDA 510(k) records for PLASTIC ATTACHABLE DUAL PORT (K912702), submitted by Davol, Inc..

• 510(k) Number: K912702
• Applicant: Davol, Inc.
• Decision Date: 09/18/1991
• Decision: Substantially Equivalent (SESE)
• Product Code: LJT LJT
• Review Panel: General Hospital
• Total PDF Pages: 137
• Fully Redacted Pages: 67
• Usable Pages: 70

Sections Included

• Administrative / Introductory Materials: pages 1; 0.0% redacted (Unredacted)
• Shelf Life: pages 2-12; 9.1% redacted (Minimal Redaction)
• Intended Use: pages 13-24; 33.3% redacted (Moderate Redaction)
• 510(k) Summary: pages 25-31; 42.9% redacted (Heavy Redaction)
• Device Description: pages 32-108; 50.6% redacted (Heavy Redaction)
• Substantial Equivalence: pages 109-137; 69.0% redacted (Heavy Redaction)