The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Atraumatic Standard Sprotte Needle.
Device ID | K911260 |
510k Number | K911260 |
Device Name: | ATRAUMATIC STANDARD SPROTTE NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | PAJUNK GMBH WASHINGTON SQUARE SUITE 1100 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
Contact | Bruce F Mackler |
Correspondent | Bruce F Mackler PAJUNK GMBH WASHINGTON SQUARE SUITE 1100 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-22 |
Decision Date | 1991-10-21 |