The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Optimumm Smoke Evacuator System.
| Device ID | K980915 |
| 510k Number | K980915 |
| Device Name: | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Charles M Copperberg |
| Correspondent | Charles M Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-11 |
| Decision Date | 1998-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524001104 | K980915 | 000 |
| 10884524001128 | K980915 | 000 |
| 10884524001135 | K980915 | 000 |
| 10884524001555 | K980915 | 000 |
| 20884524001439 | K980915 | 000 |
| 10884524000893 | K980915 | 000 |
| 10884524001449 | K980915 | 000 |
| 10884524001753 | K980915 | 000 |
| 20884524000319 | K980915 | 000 |
| 10884521134140 | K980915 | 000 |
| 20884524001071 | K980915 | 000 |
| 10884524000329 | K980915 | 000 |
| 10884524000879 | K980915 | 000 |
| 10884524000886 | K980915 | 000 |
| 10884524001081 | K980915 | 000 |
| 20884524001095 | K980915 | 000 |
| 10884524001111 | K980915 | 000 |