The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan D Bag.
| Device ID | K980005 |
| 510k Number | K980005 |
| Device Name: | MANAN D BAG |
| Classification | Bag, Bile Collecting |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
| Product Code | EXF |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-02 |
| Decision Date | 1998-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333001433 | K980005 | 000 |
| 20886333001426 | K980005 | 000 |