The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Macrobore Tubing - Cdc-f-1 Through Cdc-f-11.
| Device ID | K955896 |
| 510k Number | K955896 |
| Device Name: | MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CRITICAL DEVICE CORP. 499 NIBUS ST. Brea, CA 92621 |
| Contact | Susan D Goldsetin-falk |
| Correspondent | Susan D Goldsetin-falk CRITICAL DEVICE CORP. 499 NIBUS ST. Brea, CA 92621 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-29 |
| Decision Date | 1996-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513022732 | K955896 | 000 |
| 10810080610344 | K955896 | 000 |
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