510(k) K791059
K791059 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "POPE OTO-WICK, STERILE & NON-STERILE". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code KCN (Ear Wick), a Class I device regulated under 21 CFR 874.5220. Xomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1979
- Date Received
- June 8, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ear Wick
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type