MUCOTROL CONCENTRATED ORAL GEL WAFER
FDA 510(k) clearance K042400 · decided 2004-11-24
Clearance details
- K-number
- K042400
- Device name
- MUCOTROL CONCENTRATED ORAL GEL WAFER
- Applicant
- Belcher Pharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-03
- Decision date
- 2004-11-24
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- OLR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. recall (Z-0398-2007) | Belcher Pharmaceuticals Inc. | 2007-02-07 |