PRESSURE BARRIER KIT CAT. NO. PBK-3— 510(k) K873802
Substantially EquivalentAmerican Omni Medical, Inc.
FDA 510(k) clearance K873802 for PRESSURE BARRIER KIT CAT. NO. PBK-3, Substantially Equivalent on 1987-11-06. Applicant: American Omni Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- American Omni Medical, Inc.
- Product code
- Code DXS
- Device class
- Class 2
- Regulation
- 21 CFR 870.4310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
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