510(k) K934585
- Device
- PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL
- Applicant
- LAFAYETTE PHARMACEUTICALS, INC.
- 510(k) number
- K934585
- Product code
- FCD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-11-03
- Date received
- 1993-09-23
- Regulation
- 876.5210
- Classification name
- Barium Enema Kit
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT A SHARP
- Address
- 522 N. Earl Ave. P.O. Box 4499 Lafayette IN US 47903 47903
FDA Registration Numbers#
- 3004096300
- 3017751928
Source Documents#
Other 510(k) Records For Product Code FCD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864835 | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* | Eisai U.S.A., Inc. | 1987-02-11 |
Legacy Summary#
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FDA Review#
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