Product code KCO
- Device name
- Nasal Spray, Ent Delivery
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5220
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760674 | SYN-O-SCOPE NASAL INHALER | Mcdonald and Assoc., Inc. | 1977-03-10 |
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| 00850040983050 | WoodyKnows | M&M Pure Air Systems LLC | 2026-05-19 |
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