510(k) K990458
- Device
- STRAUMANN EXTRAORAL IMPLANT SYSTEM
- Applicant
- STRAUMANN USA
- 510(k) number
- K990458
- Product code
- KCZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-04-16
- Date received
- 1999-02-12
- Regulation
- 878.3800
- Classification name
- Prosthesis, Breast, External, Used With Adhesive
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA JALBERT
- Address
- Reservoir Pl., 1601 Trapelo Rd. Waltham MA US 02154 02154
FDA Registration Numbers#
- 8043792
- 3011548011
- 9613348
- 3023855650
- 9614404
- 9617660
- 3008395114
- 8020034
- 3007109661
- 9680655
- 3016674230
- 3016566159
- 1000641183
- 3024491894
- 8010658
- 3004134970
- 3005855077
Source Documents#
Other 510(k) Records For Product Code KCZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951324 | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | Maxol Limited L.C. | 1995-05-26 |
| K933465 | COSMET | Great Bay Medical Products, Inc. | 1994-07-20 |
| K932978 | CALSSIQUE OR MYSTIQUE | Dekumed, Kunststofftechnik Degler GmbH | 1993-12-22 |
| K932899 | CLASSIQUE | Hemispheres Marketing Co. , Ltd. | 1993-12-16 |
| K933668 | ALMOST U, INC. BREAST PROSTHESIS | Almost U., Inc. | 1993-12-10 |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | Coloplast Corp. | 1992-05-11 |
| K915382 | AMOENA AFFINITY MODEL #802 | Coloplast Corp. | 1992-01-14 |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Jobst Institute, Inc. | 1991-03-29 |
| K904085 | ELLA BREAST FORM | Coloplast A/S | 1990-10-31 |
| K904316 | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT | Coloplast Corp. | 1990-10-11 |
| K904086 | DISCRENE SELF-SUPPORTING BREAST FORM | Coloplast A/S | 1990-10-02 |
| K896533 | SPENCO BREAST FORMS | Spenco Medical Corp. | 1989-12-13 |
Legacy Summary#
summary
FDA Review#
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