The following data is part of a premarket notification filed by R-group Intl. with the FDA for R-group Intl. One Wall Puncture Needle.
| Device ID | K913267 |
| 510k Number | K913267 |
| Device Name: | R-GROUP INTL. ONE WALL PUNCTURE NEEDLE |
| Classification | Trocar |
| Applicant | R-GROUP INTL. P.O. BOX 7235 2321 NW 66TH COURT, SUITE W4 Gainesville, FL 32653 |
| Contact | Mark J Kahn |
| Correspondent | Mark J Kahn R-GROUP INTL. P.O. BOX 7235 2321 NW 66TH COURT, SUITE W4 Gainesville, FL 32653 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-23 |
| Decision Date | 1992-06-05 |