Press, Vein

Device Code: 1508

Product Code(s): JYW

Device Classification Information

• Device Type ID: 1508
• Device Name: Press, Vein
• Regulation Description: Ear, Nose, And Throat Manual Surgical Instrument.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 874.4420 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JYW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-261 CLSI M23 Fourth Edition (Replaces M23-A3)
  Development Of In Vitro Susceptibility Testing Criteria And Quality Control Parameters.

Total Product Life Cycle

• Device Type ID: 1508
• Device: Press, Vein
• Product Code: JYW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Ear, Nose, And Throat Manual Surgical Instrument.
• CFR Regulation Number: 874.4420 [🔎]

TPLC Last Update: 2019-04-02 19:55:05