510(k) K932396
- Device
- PERI-COMFORT(TM) SEATING CUSHION
- Applicant
- CHI'AM INTL.
- 510(k) number
- K932396
- Product code
- LRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-30
- Date received
- 1993-05-18
- Regulation
- 510(k) Premarket Notification
- Classification name
- Cushion, Hemorrhoid
- 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
- Gastroenterology/Urology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN WOLF
- Address
- P.O. Box 445 Circle Pines MN US 55014 55014
FDA Registration Numbers#
- 3004365956
- 3021393315
- 3016746538
- 9611956
- 3012316249
- 3008562183
- 3040389283
- 3013957847
- 3011137372
- 3043013796
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRL #
Legacy Summary#
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FDA Review#
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