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 ID | K983467 |
| 510k Number | K983467 |
| Device Name: | THERAPEP |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | DHD HEALTHCARE CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DHD HEALTHCARE CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-25 |
| Decision Date | 1999-04-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411001314 | K983467 | 000 |
Trademark Results [THERAPEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERAPEP 74507290 1993875 Live/Registered |
SMITHS MEDICAL ASD, INC. 1994-03-31 |
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