FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K Number: K964846
·
Decision Feb 12, 1997
Classifications
1
FEI Numbers
183
Registration Numbers
183
Same Product Code
80
Applicant Total
34
Review Days
71
Basic Information
- Device Name
- IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
- K Number
- K964846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- IMPLANTECH ASSOCIATES, INC.
- Date Received
- December 3, 1996
- Decision Date
- February 12, 1997
- Product Code
- MDA
- 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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
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Other Clearances by IMPLANTECH ASSOCIATES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K013732 | GELZONE | Feb 7, 2002 | Substantially Equivalent |
| K012419 | CONFORM SHEETING, MODEL IGEL | Oct 24, 2001 | Substantially Equivalent |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Nov 24, 2000 | Substantially Equivalent |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Nov 7, 1997 | Substantially Equivalent |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Oct 3, 1996 | Substantially Equivalent |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | Aug 19, 1996 | Substantially Equivalent |
| K943988 | IMPLANTECH NASAL LABIAL IMPLANT | Jan 27, 1995 | Substantially Equivalent |
| K943644 | IMPLANTECH TEMPORAL IMPLANT | Oct 18, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II | Aug 17, 1994 | Substantially Equivalent |
| K942876 | IMPLANTECH DORSAL NASAL IMPLANT | Jul 18, 1994 | Substantially Equivalent |