The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Drug Nebulizers.
| Device ID | K911422 |
| 510k Number | K911422 |
| Device Name: | DRUG NEBULIZERS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Contact | Thomas R Gunerman |
| Correspondent | Thomas R Gunerman INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267036707 | K911422 | 000 |
| 05030267163618 | K911422 | 000 |
| 05030267163595 | K911422 | 000 |
| 05030267166442 | K911422 | 000 |
| 00816472020251 | K911422 | 000 |
| 05030267079438 | K911422 | 000 |
| 05030267122554 | K911422 | 000 |
| 05030267144174 | K911422 | 000 |
| 05030267152209 | K911422 | 000 |
| 05030267147274 | K911422 | 000 |
| 05030267078707 | K911422 | 000 |
| 05030267083152 | K911422 | 000 |
| 05030267105717 | K911422 | 000 |
| 05030267104987 | K911422 | 000 |
| 05030267163588 | K911422 | 000 |