510(k) K030857
K030857 is an FDA 510(k) premarket notification submitted by Mahe Intl., Inc. for the device "MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES". The FDA issued a decision of Substantially Equivalent on October 16, 2003. The device falls under product code EOB (Nasopharyngoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4760. Mahe Intl., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2003
- Date Received
- March 18, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nasopharyngoscope (Flexible Or Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4760
- Review Panel
- EN
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).