The following data is part of a premarket notification filed by Obp Medical with the FDA for Obp Self Sealing Endoscopic Seal With Luer Lock.
| Device ID | K091838 |
| 510k Number | K091838 |
| Device Name: | OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK |
| Classification | Hysteroscope (and Accessories) |
| Applicant | OBP MEDICAL 360 MERRIMACK STREET, BUILDING#9 Lawerence, MA 01843 |
| Contact | Keith Larson |
| Correspondent | Keith Larson OBP MEDICAL 360 MERRIMACK STREET, BUILDING#9 Lawerence, MA 01843 |
| Product Code | HIH |
| Subsequent Product Code | HET |
| Subsequent Product Code | ODC |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-22 |
| Decision Date | 2009-12-04 |
| Summary: | summary |