MEDICAL MAGGOTS, CREATURE COMFORTS
FDA 510(k) clearance K072438 · decided 2007-10-05
Clearance details
- K-number
- K072438
- Device name
- MEDICAL MAGGOTS, CREATURE COMFORTS
- Applicant
- Monarch Labs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-08-30
- Decision date
- 2007-10-05
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- NQK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creat recall (Z-2207-2010) | Monarch Labs, LLC | 2010-08-11 |