The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Magill Catheter Intro. Forceps.
| Device ID | K801273 |
| 510k Number | K801273 |
| Device Name: | MAGILL CATHETER INTRO. FORCEPS |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-29 |
| Decision Date | 1980-07-28 |