510(k) K961080
- Device
- MEDIAL MALAR IMPLANT
- Applicant
- RAND SCIENTIFIC CORP.
- 510(k) number
- K961080
- Product code
- LZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-19
- Date received
- 1996-03-18
- Regulation
- 878.3550
- Classification name
- Implant, Malar
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DUANE TRACY
- Address
- 4135 Northgate Blvd. Suite 9 Sacramento CA US 95834 95834
FDA Registration Numbers#
- 1032347
- 2031444
- 2028924
- 3003897287
- 2028632
- 1825527
- 2029275
- 3013944123
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021419 | AART MALAR IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Implantech Associates, Inc. | 2000-11-24 |
| K992240 | PILLAR MALAR IMPLANT | Pillar Surgical, Inc. | 1999-11-22 |
| K983756 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| K982763 | SEARE BIOMEDICAL MALAR IMPLANTS | Seare Biomedical Corp. | 1998-09-30 |
| K981835 | SILIMED MALAR IMPLANT | Silimed, LLC | 1998-07-09 |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 |
| K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Implantech Associates, Inc. | 1997-11-07 |
| K973574 | DURALASTIC ANATOMICAL MALAR IMPLANT | Hanson Medical, Inc. | 1997-10-24 |
| K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | Allied Biomedical Corp. | 1997-07-18 |
| K970400 | BONE SOURCE HYDROXYAPATITE | Orthofix, Inc. | 1997-05-02 |
| K964443 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | 1996-12-20 |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | Implantech Associates, Inc. | 1996-08-19 |
Legacy Summary#
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FDA Review#
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