510(k) K981374
K981374 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "POREX NOSTRIL RETAINERS". The FDA issued a decision of Substantially Equivalent on July 2, 1998. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Porex Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1998
- Date Received
- April 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type