THERAPEP

Spirometer, Therapeutic (incentive)

DHD HEALTHCARE CORP.

The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Therapep.

Pre-market Notification Details

Device IDK983467
510k NumberK983467
Device Name:THERAPEP
ClassificationSpirometer, Therapeutic (incentive)
Applicant DHD HEALTHCARE CORP. 125 RASBACH ST. Canastota,  NY  13032
ContactJean Wallace
CorrespondentJean Wallace
DHD HEALTHCARE CORP. 125 RASBACH ST. Canastota,  NY  13032
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-25
Decision Date1999-04-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00607411001314 K983467 000

Trademark Results [THERAPEP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THERAPEP
THERAPEP
74507290 1993875 Live/Registered
SMITHS MEDICAL ASD, INC.
1994-03-31

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