The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Nasal/paranasal Endoscope.
Device ID | K930931 |
510k Number | K930931 |
Device Name: | NASAL/PARANASAL ENDOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Michael Southworth |
Correspondent | Michael Southworth STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-23 |
Decision Date | 1993-05-17 |