510(k) K830273
- Device
- COUNTWAY SYS. SOILED SPONGES-BLOOD LOS
- Applicant
- RITMED, INC.
- 510(k) number
- K830273
- Product code
- FQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-02-28
- Date received
- 1983-01-25
- Regulation
- 880.2740
- Classification name
- Scale, Surgical Sponge
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1317256
- 3007728276
- 3003587684
- 9613926
- 3013846070
- 1929045
- 3010805190
- 3008528424
- 2530138
- 3005044959
- 3008386534
- 3006897996
- 3001284003
- 1526534
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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