CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR
FDA 510(k) clearance K801610 · decided 1980-08-04
Clearance details
- K-number
- K801610
- Device name
- CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-15
- Decision date
- 1980-08-04
- Days to decision
- 20 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
- Mchenry, IL, 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 |
| ADAMS BREAST IMPLANT PROTECTOR (K893870) | Adept-Med Intl., Inc. | 1989-07-14 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.