The following data is part of a premarket notification filed by Dr. Howard Martin, P.a. with the FDA for Mcs-medicated Canal Sealer.
| Device ID | K973636 |
| 510k Number | K973636 |
| Device Name: | MCS-MEDICATED CANAL SEALER |
| Classification | Cement, Dental |
| Applicant | DR. HOWARD MARTIN, P.A. 4327 REELS MILL RD. Frederick, MD 21704 |
| Contact | Kyle H Sibinovic |
| Correspondent | Kyle H Sibinovic DR. HOWARD MARTIN, P.A. 4327 REELS MILL RD. Frederick, MD 21704 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-24 |
| Decision Date | 1998-07-27 |