510(k) K852642
K852642 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "CENTRAL VEIN CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent on January 16, 1986. The device falls under product code FDZ (Attachment, Eyepiece, For Insertion Of Prescription Lens), a Class I device regulated under 21 CFR 876.1500. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1986
- Date Received
- June 21, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Eyepiece, For Insertion Of Prescription Lens
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type