The following data is part of a premarket notification filed by Geister Medizintechnik Gmbh with the FDA for Atraumatic Vascular Clamps, Model #'s 22-xxxx, 23-xxxx, 03-60xx, 25-xxxx Micro Vascular Clamps Model # 75-0xxx, Atraumat.
| Device ID | K982365 |
| 510k Number | K982365 |
| Device Name: | ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT |
| Classification | Clamp, Vascular |
| Applicant | GEISTER MEDIZINTECHNIK GMBH FOEHRENSTR. 2 Tuttlingen, DE D-78532 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser GEISTER MEDIZINTECHNIK GMBH FOEHRENSTR. 2 Tuttlingen, DE D-78532 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-07 |
| Decision Date | 1999-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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