ADAMS BREAST IMPLANT PROTECTOR
FDA 510(k) clearance K893870 · decided 1989-07-14
Clearance details
- K-number
- K893870
- Device name
- ADAMS BREAST IMPLANT PROTECTOR
- Applicant
- Adept-Med Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-26
- Decision date
- 1989-07-14
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GCZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cameron Park, CA, 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 |
|---|---|---|
| JAIN GRAFT ASSIST (K904536) | Jain Surgical Equipment, Inc. | 1990-11-29 |
| MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (K870809) | Adept-Med Intl., Inc. | 1987-03-19 |
| VISECERA RETAINER (K802806) | Adept-Med Intl., Inc. | 1981-01-23 |
| CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR (K801610) | Edward Weck, Inc. | 1980-08-04 |
Recalls involving this device
No recalls on record reference this clearance.