510(k) K974232
K974232 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "ESSENTIAL SHAVER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 1998. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1998
- Date Received
- November 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bur, Ear, Nose And Throat
- Device Class
- Class I
- Regulation Number
- 874.4140
- Review Panel
- EN
- Submission Type