REUSEABLE HOT & COLD PACKS— 510(k) K810451
Substantially EquivalentFred Sammons, Inc.
FDA 510(k) clearance K810451 for REUSEABLE HOT & COLD PACKS, Substantially Equivalent on 1981-03-04. Applicant: Fred Sammons, Inc.. Device class: 1.
Clearance details
- Applicant
- Fred Sammons, Inc.
- Product code
- Code IME
- Device class
- Class 1
- Regulation
- 21 CFR 890.5700
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IME
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view allAdverse events under product code IME
product code IME- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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