FRANK INHALER THERMAL S

Nebulizer, Medicinal, Non-ventilatory (atomizer)

The following data is part of a premarket notification filed by Buttner-frank Gmbh with the FDA for Frank Inhaler Thermal S.

Device ID	K895115
510k Number	K895115
Device Name:	FRANK INHALER THERMAL S
Classification	Nebulizer, Medicinal, Non-ventilatory (atomizer)
Applicant	BUTTNER-FRANK GMBH 8520 ERLANGEN-TENNENLOHE AM WOLFSMANTEL 9/GEWERBEGABIET Postfach 1266, DE
Contact	Blank
Correspondent	Blank BUTTNER-FRANK GMBH 8520 ERLANGEN-TENNENLOHE AM WOLFSMANTEL 9/GEWERBEGABIET Postfach 1266, DE
Product Code	CCQ
CFR Regulation Number	868.5640 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	1989-08-15
Decision Date	1990-05-18