The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Clm Laryngoscope.
| Device ID | K953179 |
| 510k Number | K953179 |
| Device Name: | CLM LARYNGOSCOPE |
| Classification | Laryngoscope, Rigid |
| Applicant | PENLON LTD. RADLEY ROAD AINGDON Oxonn, GB Ox14 3ph |
| Contact | A. C. Green |
| Correspondent | A. C. Green PENLON LTD. RADLEY ROAD AINGDON Oxonn, GB Ox14 3ph |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1995-10-06 |