510(k) K072690
- Device
- HEMAWAY SEAT
- Applicant
- HEMAWAY LLC
- 510(k) number
- K072690
- Product code
- LRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-07
- Date received
- 2007-09-24
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARCHIE ROSENBLUM
- Address
- 2207 Concord Pike, Suite 528 Wilmington DE US 19803 19803
FDA Registration Numbers#
- 3004365956
- 3021393315
- 3016746538
- 9611956
- 3012316249
- 3008562183
- 3040389283
- 3013957847
- 3011137372
- 3043013796
Source Documents#
Other 510(k) Records For Product Code LRL #
Legacy Summary#
summary
FDA Review#
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