PHEM-ALERT
Paper, Obstetric Ph
FEMTEK,LLC.
The following data is part of a premarket notification filed by Femtek,llc. with the FDA for Phem-alert.
Pre-market Notification Details
| Device ID | K032161 |
| 510k Number | K032161 |
| Device Name: | PHEM-ALERT |
| Classification | Paper, Obstetric Ph |
| Applicant | FEMTEK,LLC. 11605 HITCHING POST LN. Rockville, MD 20852 |
| Contact | Joel S Faden |
| Correspondent | Joel S Faden FEMTEK,LLC. 11605 HITCHING POST LN. Rockville, MD 20852 |
| Product Code | LNW |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-15 |
| Decision Date | 2003-09-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| GYNXPH990 | K032161 | 000 |
Trademark Results [PHEM-ALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHEM-ALERT 75151511 2192630 Live/Registered |
CAILLOUETTE, JAMES C. 1996-08-16 |
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