510(k) K802285
- Device
- OHIO THORACIC SUCTION REGULATOR
- Applicant
- OHIO MEDICAL PRODUCTS
- 510(k) number
- K802285
- Product code
- KOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-03
- Date received
- 1980-09-19
- Regulation
- 872.3450
- Classification name
- Adhesive, Denture, Karaya
- Medical specialty
- Dental
- Review panel
- Dental
- 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#
- 3009171220
- 3043303267
- 3010002722
- 3017953780
- 3006237499
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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