Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TENNANT(TM) & KELMAN(TM) TYPE II |
Generic Name | Transducer, ultrasonic, obstetric |
Regulation Number | 884.2960 |
Applicant | Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 |
PMA Number | P800016 |
Supplement Number | S007 |
Date Received | 04/16/1986 |
Decision Date | 06/13/1986 |
Withdrawal Date
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11/26/2008 |
Product Code |
HGL |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
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