The following data is part of a premarket notification filed by Geister Medizintechnik Gmbh with the FDA for Kamar Annulus Dilator + Sizer; Garrett, Cooley, And Debakey Vessel Dilators.
| Device ID | K030788 |
| 510k Number | K030788 |
| Device Name: | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS |
| Classification | Dilator, Vessel, Surgical |
| Applicant | GEISTER MEDIZINTECHNIK GMBH AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser GEISTER MEDIZINTECHNIK GMBH AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-12 |
| Decision Date | 2003-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2743104621 | K030788 | 000 |
| M2743103881 | K030788 | 000 |
| M2743103871 | K030788 | 000 |
| M2743103861 | K030788 | 000 |
| M2743103851 | K030788 | 000 |
| M2743104041 | K030788 | 000 |
| M2743104031 | K030788 | 000 |
| M2743104021 | K030788 | 000 |
| M2743104011 | K030788 | 000 |
| M2743104001 | K030788 | 000 |
| M2743103991 | K030788 | 000 |
| M2743103981 | K030788 | 000 |
| M2743103971 | K030788 | 000 |
| M2743103961 | K030788 | 000 |
| M2743103951 | K030788 | 000 |
| M2743103891 | K030788 | 000 |
| M2743103901 | K030788 | 000 |
| M2743103911 | K030788 | 000 |
| M2743104611 | K030788 | 000 |
| M2743104601 | K030788 | 000 |
| M2743104591 | K030788 | 000 |
| M2743104581 | K030788 | 000 |
| M2743104571 | K030788 | 000 |
| M2743104561 | K030788 | 000 |
| M2743104551 | K030788 | 000 |
| M2743104541 | K030788 | 000 |
| M2743104531 | K030788 | 000 |
| M2743104521 | K030788 | 000 |
| M2743104511 | K030788 | 000 |
| M2743104501 | K030788 | 000 |
| M2743103931 | K030788 | 000 |
| M2743103921 | K030788 | 000 |
| M2743103941 | K030788 | 000 |