510(k) DEN990005
- Device
- THE 3PM EGG MACHINE
- Applicant
- 3pm Co., Inc.
- 510(k) number
- DEN990005
- Product code
- MYE
- Decision
- Unknown (DENG)
- Decision date
- 1999-08-20
- Date received
- 1999-07-12
- Regulation
- 876.1735
- Classification name
- System, Electrogastrography (Egg)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DANIEL J MANELLI
- Address
- 2000 M St., NW 7th Floor Washington DC US 20036 20036
FDA Registration Numbers#
- 3030686085
- 2954356
- 3023209868
Source Documents#
510(k) summary PDF not indicated by FDA
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