The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman(r) Ridig And Steerable Endoscope Holder, Model 83-1352.
| Device ID | K945572 |
| 510k Number | K945572 |
| Device Name: | CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352 |
| Classification | Endoscope, Neurological |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | Patricia Bankert |
| Correspondent | Patricia Bankert JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-02-03 |