The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical Forceps.
| Device ID | K134047 |
| 510k Number | K134047 |
| Device Name: | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS |
| Classification | Forceps, Surgical, Gynecological |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Contact | Ruthanne Vendy |
| Correspondent | Ruthanne Vendy INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Product Code | HCZ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-04-11 |
| Summary: | summary |