The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Insulated Speculum W/ Smoke Evacuator Option.
| Device ID | K922154 |
| 510k Number | K922154 |
| Device Name: | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Contact | Eugene W Olsen |
| Correspondent | Eugene W Olsen OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord, CA 94520 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-07 |
| Decision Date | 1994-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841785107672 | K922154 | 000 |
| 00841785107641 | K922154 | 000 |
| 00841785107634 | K922154 | 000 |
| 00841785107573 | K922154 | 000 |
| 00841785107566 | K922154 | 000 |
| 00841785107559 | K922154 | 000 |