The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Sterile Endoscopic Dispos Trocars W/safe Shield.
| Device ID | K924761 |
| 510k Number | K924761 |
| Device Name: | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-23 |
| Decision Date | 1993-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405035859 | K924761 | 000 |
| 10653405001904 | K924761 | 000 |
| 10653405035114 | K924761 | 000 |
| 10653405035138 | K924761 | 000 |
| 10653405035152 | K924761 | 000 |
| 10653405001911 | K924761 | 000 |
| 10653405001836 | K924761 | 000 |
| 10653405034636 | K924761 | 000 |
| 10653405034896 | K924761 | 000 |
| 10653405034919 | K924761 | 000 |
| 10653405034940 | K924761 | 000 |
| 10653405034957 | K924761 | 000 |
| 10653405034971 | K924761 | 000 |
| 10653405034995 | K924761 | 000 |
| 10653405035008 | K924761 | 000 |
| 10653405035176 | K924761 | 000 |
| 10653405035206 | K924761 | 000 |
| 10653405040798 | K924761 | 000 |
| 10653405035190 | K924761 | 000 |