The following data is part of a premarket notification filed by Zimmar Consulting Ltd. with the FDA for Pharma-plast Rectal Tip.
| Device ID | K843477 |
| 510k Number | K843477 |
| Device Name: | PHARMA-PLAST RECTAL TIP |
| Classification | Instrument, Biopsy, Mechanical, Gastrointestinal |
| Applicant | ZIMMAR CONSULTING LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FCF |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-12-05 |