510(k) K842679
K842679 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "ESOPHAGEAL DILATOR SET". The FDA issued a decision of Substantially Equivalent on October 2, 1984. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1984
- Date Received
- July 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
- Device Class
- Class II
- Regulation Number
- 876.5365
- Review Panel
- GU
- Submission Type