The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Keyport System, Includes: Keyport Silicone Sealing Insert 8850xxx Keyport Trucar 8850xx Keyport Trocar 8850xx Sealing Ca.
| Device ID | K120898 |
| 510k Number | K120898 |
| Device Name: | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-08-03 |
| Summary: | summary |