510(k) K822258
K822258 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "ESOPHAGEAL BOUGIES". The FDA issued a decision of Substantially Equivalent on August 25, 1982. The device falls under product code KCD (Bougie, Esophageal, Ent), a Class I device regulated under 21 CFR 874.4420. Kelleher Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1982
- Date Received
- July 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bougie, Esophageal, Ent
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type