The following data is part of a premarket notification filed by Mend Technologies, Inc. with the FDA for Cervical Biopsy Instrument.
| Device ID | K883867 |
| 510k Number | K883867 |
| Device Name: | CERVICAL BIOPSY INSTRUMENT |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | MEND TECHNOLOGIES, INC. 5757 ALPHA RD. SUITE 304 Dallas, TX 75240 |
| Contact | T. H Parke |
| Correspondent | T. H Parke MEND TECHNOLOGIES, INC. 5757 ALPHA RD. SUITE 304 Dallas, TX 75240 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-11-29 |