The following data is part of a premarket notification filed by Penlon Limited with the FDA for Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454.
| Device ID | K053564 |
| 510k Number | K053564 |
| Device Name: | KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PENLON LIMITED 25 BARKER CLOSE FISHBOURNE, CHICHESTER West Sussex, GB Po18 8bj |
| Contact | Barry Pearce |
| Correspondent | Barry Pearce PENLON LIMITED 25 BARKER CLOSE FISHBOURNE, CHICHESTER West Sussex, GB Po18 8bj |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051977000444 | K053564 | 000 |
| 05051977000314 | K053564 | 000 |
| 05051977000260 | K053564 | 000 |
| 05051977000222 | K053564 | 000 |