510(k) K821836
- Device
- PREGNANCY (W) EDGE
- Applicant
- BODY THERAPEUTICS, INC.
- 510(k) number
- K821836
- Product code
- MPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-30
- Date received
- 1982-06-22
- Regulation
- 510(k) Premarket Notification
- Classification name
- Contraception Calculator
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1000626221
- 1026765
- 3029994331
- 3035878914
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MPT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954183 | OVULATION CALCULATOR/CONCEPTION CALCULATOR | Hector Vides | 1996-02-29 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases