The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Rdp-2.
| Device ID | K961922 |
| 510k Number | K961922 |
| Device Name: | RDP-2 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Contact | Raymond D Langley |
| Correspondent | Raymond D Langley RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK Avon, MA 02322 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-08-09 |