The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Laparoscopic Instruments.
| Device ID | K043013 |
| 510k Number | K043013 |
| Device Name: | MILTEX LAPAROSCOPIC INSTRUMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Charles Weaver |
| Correspondent | Charles Weaver MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-02 |
| Decision Date | 2005-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834353001 | K043013 | 000 |
| H834351101 | K043013 | 000 |
| H834354001 | K043013 | 000 |
| H834352001 | K043013 | 000 |
| H834352031 | K043013 | 000 |
| H834354011 | K043013 | 000 |
| H834354021 | K043013 | 000 |
| H834352021 | K043013 | 000 |
| H834352051 | K043013 | 000 |
| H834353021 | K043013 | 000 |
| H834353011 | K043013 | 000 |
| H834352011 | K043013 | 000 |
| H834352041 | K043013 | 000 |