The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Inman Endoscopic Blunt Dissector.
Device ID | K933169 |
510k Number | K933169 |
Device Name: | INMAN ENDOSCOPIC BLUNT DISSECTOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Contact | John Mayall |
Correspondent | John Mayall INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-29 |
Decision Date | 1994-04-19 |