510(k) K760674
K760674 is an FDA 510(k) premarket notification submitted by Mcdonald and Assoc., Inc. for the device "SYN-O-SCOPE NASAL INHALER". The FDA issued a decision of Substantially Equivalent on March 10, 1977. The device falls under product code KCO (Nasal Spray, Ent Delivery), a Class I device regulated under 21 CFR 874.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1977
- Date Received
- September 16, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nasal Spray, Ent Delivery
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type