FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADAMS BREAST IMPLANT PROTECTOR
K Number: K893870
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
4
Applicant Total
6
Review Days
49
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Basic Information
- Device Name
- ADAMS BREAST IMPLANT PROTECTOR
- K Number
- K893870
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Adept-Med Intl., Inc.
- Date Received
- May 26, 1989
- Decision Date
- July 14, 1989
- Product Code
- GCZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCZ | Retainer, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCZ), ordered by most recent decision date.
JAIN GRAFT ASSIST
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VISECERA RETAINER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Adept-Med Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935636 | GRAVESPEC | Mar 25, 1994 | Substantially Equivalent |
| K893871 | GOOTT BALFOUR BLADE | Aug 3, 1989 | Substantially Equivalent |
| K893869 | GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) | Aug 3, 1989 | Substantially Equivalent |
| K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | Mar 19, 1987 | Substantially Equivalent |
| K802806 | VISECERA RETAINER | Jan 23, 1981 | Substantially Equivalent |