510(k) K000620
- Device
- PBN FALLOPIAN TUBE CATHETER SYSTEM
- Applicant
- MEDICAL DEVICE TECHNOLOGIES, INC.
- 510(k) number
- K000620
- Product code
- MDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-10-30
- Date received
- 2000-02-24
- Regulation
- 884.4530
- Classification name
- System, Intrafallopian Cannula
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KARL SWARTZ
- Address
- 3600 S.W 47th Ave. Gainesville FL US 32608 32608
FDA Registration Numbers#
- 3004111573
- 1625425
Source Documents#
Legacy Summary#
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FDA Review#
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