MY BREAST FRIEND, BREAST SELF-EXAM PAD
FDA 510(k) clearance K023390 · decided 2002-11-26
Clearance details
- K-number
- K023390
- Device name
- MY BREAST FRIEND, BREAST SELF-EXAM PAD
- Applicant
- Mbf Sales, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-10-09
- Decision date
- 2002-11-26
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- IXH
- Device class
- 1
- Regulation number
- 892.1940
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SLIT CAMERA MODEL 07-624 (K851811) | Victoreen, Inc. | 1985-05-28 |
Recalls involving this device
No recalls on record reference this clearance.