510(k) K955233
K955233 is an FDA 510(k) premarket notification submitted by Corbett Lair, Inc. for the device "EASY BREATHING NASAL STRIPS". The FDA issued a decision of Substantially Equivalent on December 21, 1995. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900. Corbett Lair, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1995
- Date Received
- November 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Nasal
- Device Class
- Class I
- Regulation Number
- 874.3900
- Review Panel
- EN
- Submission Type