The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Epilong Kit For Anesthesiology.
Device ID | K060311 |
510k Number | K060311 |
Device Name: | EPILONG KIT FOR ANESTHESIOLOGY |
Classification | Anesthesia Conduction Kit |
Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
Contact | Christian Quass |
Correspondent | Christian Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-08 |
Decision Date | 2006-06-13 |
Summary: | summary |