510(k) K844169
K844169 is an FDA 510(k) premarket notification submitted by Glaxo, Inc. for the device "VOLUMATIC". The FDA issued a decision of Substantially Equivalent on November 9, 1984. The device falls under product code KCD (Bougie, Esophageal, Ent), a Class I device regulated under 21 CFR 874.4420. Glaxo, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1984
- Date Received
- October 25, 1984
- 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