ESOPHAGEAL DILATOR SET— 510(k) K842679
Substantially EquivalentMill-Rose Laboratory
FDA 510(k) clearance K842679 for ESOPHAGEAL DILATOR SET, Substantially Equivalent on 1984-10-02. Applicant: Mill-Rose Laboratory. Device class: 2.
Clearance details
- Applicant
- Mill-Rose Laboratory
- Product code
- Code FAT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5365
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.