CLASSIQUE
Prosthesis, Breast, External, Used With Adhesive
HEMISPHERES MARKETING CO. LTD.
The following data is part of a premarket notification filed by Hemispheres Marketing Co. Ltd. with the FDA for Classique.
Pre-market Notification Details
| Device ID | K932899 |
| 510k Number | K932899 |
| Device Name: | CLASSIQUE |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | HEMISPHERES MARKETING CO. LTD. 6501 N.W. 36TH STREET, #101 Miami, FL 33166 |
| Contact | Lewis |
| Correspondent | Lewis HEMISPHERES MARKETING CO. LTD. 6501 N.W. 36TH STREET, #101 Miami, FL 33166 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1993-12-16 |
Trademark Results [CLASSIQUE]
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