The following data is part of a premarket notification filed by Vernon-carus Limited with the FDA for Nubert, Albert And Hubert Impervious Bags For Endoscopic Retrieval Of Tissue.
| Device ID | K033842 |
| 510k Number | K033842 |
| Device Name: | NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VERNON-CARUS LIMITED PO BOX 2608 Morgan Hill, CA 95038 |
| Contact | C. Robert Payne, Jr., P.e. |
| Correspondent | C. Robert Payne, Jr., P.e. VERNON-CARUS LIMITED PO BOX 2608 Morgan Hill, CA 95038 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05019829240004 | K033842 | 000 |
| 05019829240042 | K033842 | 000 |
| 05019829240073 | K033842 | 000 |