The following data is part of a premarket notification filed by Ranfac Corp. with the FDA for Introducer.
| Device ID | K951090 |
| 510k Number | K951090 |
| Device Name: | INTRODUCER |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812608021550 | K951090 | 000 |
| 00812608021536 | K951090 | 000 |
| 10812608021038 | K951090 | 000 |