The following data is part of a premarket notification filed by New Wave Surgical Corporation with the FDA for Defogging Heated Endoscope Lens Protector (dhelp); Defogging Endoscope Lens Protector (delp).
| Device ID | K062779 |
| 510k Number | K062779 |
| Device Name: | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NEW WAVE SURGICAL CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11011 |
| Contact | Sid Mathur |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521213569 | K062779 | 000 |