The following data is part of a premarket notification filed by Trylon Corp. with the FDA for Spirabrush Cx Biopsy Instrument.
| Device ID | K011488 |
| 510k Number | K011488 |
| Device Name: | SPIRABRUSH CX BIOPSY INSTRUMENT |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | TRYLON CORP. 970 WEST 190TH ST., SUITE 850 Torrance, CA 90502 -1037 |
| Contact | Martin Lonky |
| Correspondent | Martin Lonky TRYLON CORP. 970 WEST 190TH ST., SUITE 850 Torrance, CA 90502 -1037 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-15 |
| Decision Date | 2002-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860275000309 | K011488 | 000 |